Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Avastin (Bevacizumab) + Xeloda (Capecitabine)as Maintenance Therapy in Patients With HER2-Negative Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00929240
Recruitment Status : Completed
First Posted : June 26, 2009
Results First Posted : March 3, 2015
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: bevacizumab [Avastin]
Drug: capecitabine [Xeloda]
Enrollment 287
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Initial Treatment Phase: Bevacizumab Plus (+) Docetaxel Maintenance Phase: Bevacizumab Maintenance Phase: Bevacizumab + Capecitabine
Hide Arm/Group Description During the Initial Phase all participants received bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first. Participants also received docetaxel, a recommended dose of 100 milligrams per square meter (mg/m^2) IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine. During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (partial response [PR] or complete response [CR]) or disease stabilization (SD) received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first. During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
Period Title: Initial Treatment Phase
Started 284 [1] 0 [2] 0
Completed 185 [2] 0 0
Not Completed 99 0 0
Reason Not Completed
Adverse Event             31             0             0
Disease progression             41             0             0
Withdrawal by Subject             13             0             0
Protocol Violation             5             0             0
Death             2             0             0
Health authority/Study termination             3             0             0
Physician Decision             4             0             0
[1]
Includes only the participants that received Initial Phase Treatment.
[2]
Participants were randomized to 1 of 2 treatment groups at the end of the initial treatment phase.
Period Title: Maintenance Phase
Started 0 [1] 94 91
Completed 0 0 0
Not Completed 0 94 91
Reason Not Completed
Disease progression             0             73             60
Adverse Event             0             9             12
Withdrawal by Subject             0             2             6
Protocol Violation             0             1             0
Health authority/Study termination             0             1             2
Physician Decision             0             2             1
Change of treatment             0             4             0
Treatment ongoing at study closure             0             0             10
Participant not treated             0             2             0
[1]
Participants were randomized to 1 of 2 treatment groups at the end of the initial treatment phase.
Arm/Group Title Intial Treatment Phase: Bevacizumab + Docetaxel
Hide Arm/Group Description During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first. Participants also received docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
Overall Number of Baseline Participants 287
Hide Baseline Analysis Population Description
Initial Phase Intent-to-Treat (ITT) population: all participants who were enrolled.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 287 participants
52.5  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 287 participants
Female
287
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Disease Progression or Death (Maintenance Phase Data Cutoff October 4, 2013)
Hide Description Progression Free Survival (PFS) was defined as the time from first study drug dosing (during the maintenance treatment phase) to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST). Progressive Disease (PD) was defined as a 20 percent (%) or greater increase in the sum of the Longest Diameter (LD) of the target lesions taking as reference the smallest sum LD recorded or appearance of new lesions.
Time Frame Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Maintenance Phase ITT population: All randomized participants
Arm/Group Title Maintenance Phase: Bevacizumab Maintenance Phase: Bevacizumab + Capecitabine
Hide Arm/Group Description:
During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
Overall Number of Participants Analyzed 94 91
Measure Type: Number
Unit of Measure: percentage of participants
88.3 75.8
2.Primary Outcome
Title Progression Free Survival (Maintenance Phase Data Cutoff October 4, 2013)
Hide Description PFS was defined as the time from first study drug dosing to the first documented disease progression or death, whichever occurred first.Time to progression was defined as the time from randomization to the first documented disease progression defined per RECIST 1.0 criteria. Participants without an event at data cut-off or who were withdrawn from the study without documented progression were censored at the date of the last tumor assessment when the participant was known to be progression free. Participants who took other non-protocol anti-cancer drugs while being on study medication, and who were still event free were censored on the date of first dose of the anti-cancer drug. Participants without post-randomization tumor assessments but alive were censored at the time of randomization. Participants without post-randomization assessments, who died after randomization were considered to have the PFS event at date of death. Kaplan-Meier estimation was used for median time to PFS
Time Frame Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Maintenance Phase ITT population
Arm/Group Title Maintenance Phase: Bevacizumab Maintenance Phase: Bevacizumab + Capecitabine
Hide Arm/Group Description:
During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
Overall Number of Participants Analyzed 94 91
Median (95% Confidence Interval)
Unit of Measure: months
4.3
(3.9 to 6.8)
11.9
(9.8 to 15.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Phase: Bevacizumab, Maintenance Phase: Bevacizumab + Capecitabine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Stratified by interactive voice/Web response system (IVRS), estrogen receptor (ER) status, visceral metastasis (yes/no), response to initial phase, and lactate dehydrogenase (LDH) level.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.383
Confidence Interval (2-Sided) 95%
0.266 to 0.551
Estimation Comments Stratified by IVRS, ER status, visceral metastasis (yes/no), response to initial phase, and LDH level.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maintenance Phase: Bevacizumab, Maintenance Phase: Bevacizumab + Capecitabine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments Unstratified analysis
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.429
Confidence Interval (2-Sided) 95%
0.309 to 0.597
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Best Overall Confirmed Objective Response of CR or PR Per RECIST 1.0 (Maintenance Phase Data Cutoff October 4, 2013)
Hide Description Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. Progressive disease (PD) was defined as 20% increase in the sum of the longest diameter of target lesions and SD was defined as small changes that do not meet above criteria. Pearson-Clopper one-sample method was used for Confidence intervals (CIs).
Time Frame Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Maintenance Phase ITT Population
Arm/Group Title Maintenance Phase: Bevacizumab Maintenance Phase: Bevacizumab + Capecitabine
Hide Arm/Group Description:
During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
Overall Number of Participants Analyzed 94 91
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
76.6
(66.7 to 84.7)
85.7
(76.8 to 92.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Phase: Bevacizumab, Maintenance Phase: Bevacizumab + Capecitabine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.113
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.1
Confidence Interval (2-Sided) 95%
-2.1 to 20.3
Estimation Comments CIs with Hauck-Anderson adjustment for difference in rates of bevacizumab + capecitabine arm to bevacizumab alone arm.
4.Secondary Outcome
Title Percentage of Participants With Clinical Benefit (CR, PR and SD) Per RECIST 1.0 (Data Cutoff October 4, 2013)
Hide Description CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as ≥ 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. SD was defined as small changes that do not meet above criteria.
Time Frame Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Maintenance Phase ITT population
Arm/Group Title Maintenance Phase: Bevacizumab Maintenance Phase: Bevacizumab + Capecitabine
Hide Arm/Group Description:
During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
Overall Number of Participants Analyzed 94 91
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97.9
(92.5 to 99.7)
98.9
(94.0 to 100.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Phase: Bevacizumab, Maintenance Phase: Bevacizumab + Capecitabine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.580
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-2.6 to 4.6
Estimation Comments CIs with Hauck-Anderson adjustment for difference in rates of Bevacizumab+Capecitabine group to Bevacizumab only group.
5.Secondary Outcome
Title Percentage of Participants Who Died (Maintenance Phase Data Cutoff October 4, 2013)
Hide Description [Not Specified]
Time Frame Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Maintenance Phase ITT population
Arm/Group Title Maintenance Phase: Bevacizumab Maintenance Phase: Bevacizumab + Capecitabine
Hide Arm/Group Description:
During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
Overall Number of Participants Analyzed 94 91
Measure Type: Number
Unit of Measure: percentage of participants
56.4 36.3
6.Secondary Outcome
Title Overall Survival (Maintenance Phase Data Cutoff October 4, 2013)
Hide Description Duration of Overall Survival (OS) was defined as the time from randomization to death of any cause. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive. Kaplan Meier estimation was used to determine OS.
Time Frame Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Maintenance Phase ITT population
Arm/Group Title Maintenance Phase: Bevacizumab Maintenance Phase: Bevacizumab + Capecitabine
Hide Arm/Group Description:
During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
Overall Number of Participants Analyzed 94 91
Median (95% Confidence Interval)
Unit of Measure: months
23.7
(18.5 to 31.7)
39.0 [1] 
(32.3 to NA)
[1]
Upper Confidence limit was not estimated because of the large number of censored events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Phase: Bevacizumab, Maintenance Phase: Bevacizumab + Capecitabine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0003
Comments Stratified by IVRS, ER status, visceral metastasis (yes/no), response to initial phase, and LDH level.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.425
Confidence Interval (2-Sided) 95%
0.263 to 0.685
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maintenance Phase: Bevacizumab, Maintenance Phase: Bevacizumab + Capecitabine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Unstratified analysis
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.516
Confidence Interval (2-Sided) 95%
0.334 to 0.798
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants Expected to Be Alive After 1 and 2 Years on Treatment (Maintenance Phase Data Cutoff October 4, 2013)
Hide Description Probability of being alive after 1 and 2 years on treatment with 95% CIs was calculated using Kaplan Meier approach with LOGLOG transformation.
Time Frame Years 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
Maintenance Phase ITT Population
Arm/Group Title Maintenance Phase: Bevacizumab Maintenance Phase: Bevacizumab + Capecitabine
Hide Arm/Group Description:
During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
Overall Number of Participants Analyzed 94 91
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1 Year
71.6
(61.1 to 79.7)
90.4
(81.8 to 95.1)
2 Years
49.4
(38.5 to 59.3)
69.0
(57.6 to 77.9)
8.Secondary Outcome
Title Percentage Of Participants With PD or Death Due to PD (Maintenance Phase Data Cutoff October 4, 2013)
Hide Description PD was defined per RECIST 1.0 as 20% increase in the sum of the longest diameter of target lesions.
Time Frame Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013
Hide Outcome Measure Data
Hide Analysis Population Description
Maintenance Phase ITT population
Arm/Group Title Maintenance Phase: Bevacizumab Maintenance Phase: Bevacizumab + Capecitabine
Hide Arm/Group Description:
During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
Overall Number of Participants Analyzed 94 91
Measure Type: Number
Unit of Measure: percentage of participants
88.3 74.7
9.Secondary Outcome
Title Time To Progression (Maintenance Phase Data Cutoff October 4, 2013)
Hide Description Time to Progression was defined as the time from randomization to the first documented disease progression (using investigator assessments of disease progression by RECIST 1.0). PD was defined as 20% increase in the sum of the longest diameter of target lesions.
Time Frame Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013
Hide Outcome Measure Data
Hide Analysis Population Description
Maintenance Phase ITT population
Arm/Group Title Maintenance Phase: Bevacizumab Maintenance Phase: Bevacizumab + Capecitabine
Hide Arm/Group Description:
During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
Overall Number of Participants Analyzed 94 91
Median (95% Confidence Interval)
Unit of Measure: months
4.3
(3.9 to 6.8)
11.9
(9.8 to 15.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Phase: Bevacizumab, Maintenance Phase: Bevacizumab + Capecitabine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Stratified by IVRS, ER status, visceral metastasis (yes/no), response to initial phase, and LDH level.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.383
Confidence Interval (2-Sided) 95%
0.266 to 0.551
Estimation Comments Stratification variables are randomisation stratification parameters as of IVRS: ER status, Visceral metastasis (yes/no), Response to initial phase, LDH concentration level.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maintenance Phase: Bevacizumab, Maintenance Phase: Bevacizumab + Capecitabine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Unstratified analysis
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.425
Confidence Interval (2-Sided) 95%
0.305 to 0.591
Estimation Comments Hazard ratio was determined using the cox regression model.
10.Secondary Outcome
Title Quality of Life Assessed As Change From Baseline in Global Health Status Using The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - 30 (EORTC QLQ - C30) (Maintenance Phase Data Cutoff October 4, 2013)
Hide Description The EORTC QLQ-C30 incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnoea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. The change in global health status was determined to be the difference in values at baseline and each specific visit. The term ''baseline'' refers to the time of randomization to the maintenance phase.
Time Frame Baseline, Randomization and Cycles 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Maintenance Phase ITT population; n (number) = number of participants analyzed at the specific visit. Only timepoints with more than 10 participants in each treatment arm are presented.
Arm/Group Title Maintenance Phase: Bevacizumab Maintenance Phase: Bevacizumab + Capecitabine
Hide Arm/Group Description:
During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
Overall Number of Participants Analyzed 83 86
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Randomization (n= 83, 86)
-3.51
(-9.63 to 2.60)
-4.46
(-9.40 to 0.48)
Cycle 3 (n= 44, 52)
0.76
(-6.65 to 8.17)
-3.21
(-9.99 to 3.58)
Cycle 6 (n= 26, 54)
4.17
(-6.49 to 14.82)
-5.40
(-11.67 to 0.87)
Cycle 9 (n= 18, 37)
8.80
(-4.57 to 22.17)
-1.80
(-8.92 to 5.32)
Cycle 12 (n= 12, 31)
0.69
(-17.99 to 19.37)
0.00
(-8.24 to 8.24)
11.Secondary Outcome
Title Percentage of Participants With Best Overall Confirmed Objective Response of CR or PR Per RECIST 1.0 (Initial Treatment Phase)
Hide Description Objective Response was determined by the investigator using RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as ≥ 30% decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. Pearson-Clopper one-sample method was used for CI.
Time Frame Screening and at the end of every third cycle until randomization for an average of 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Initial Phase ITT population; only participants who were not randomized at the end of the initial treatment phase were included in this analysis.
Arm/Group Title Initial Treatment Phase: Bevacizumab + Docetaxel
Hide Arm/Group Description:
During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first, along with docetaxel a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion.At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
Overall Number of Participants Analyzed 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.8
(4.1 to 16.1)
12.Secondary Outcome
Title Percentage of Participants With Clinical Benefit (CR, PR and SD) Per RECIST 1.0 (Initial Treatment Phase)
Hide Description CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as ≥30% decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. SD was defined as small changes that do not meet above criteria.
Time Frame Screening and at the end of every third cycle until randomization for an average of 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Initial Phase ITT population; only participants who were not randomized at the end of the initial treatment phase were included in this analysis.
Arm/Group Title Initial Treatment Phase: Bevacizumab + Docetaxel
Hide Arm/Group Description:
During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first, along with docetaxel a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
Overall Number of Participants Analyzed 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
56.9
(46.7 to 66.6)
Time Frame Adverse Events (AEs) were recorded from the date of randomization until the end of study at the cutoff date of October 4, 2013.
Adverse Event Reporting Description AEs were recorded for the Safety population (all participants who received at least one dose of study drug during the maintenance phase). Only Grade 3 and above AEs have been captured per protocol.
 
Arm/Group Title Initial Treatment Phase:Bevacizumab + Docetaxel Maintenance Phase:Bevacizumab Maintenance Phase: Bevacizumab + Capecitabine
Hide Arm/Group Description During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first. Participants also received docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine. During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first. During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
All-Cause Mortality
Initial Treatment Phase:Bevacizumab + Docetaxel Maintenance Phase:Bevacizumab Maintenance Phase: Bevacizumab + Capecitabine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Initial Treatment Phase:Bevacizumab + Docetaxel Maintenance Phase:Bevacizumab Maintenance Phase: Bevacizumab + Capecitabine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   78/284 (27.46%)   7/92 (7.61%)   10/91 (10.99%) 
Blood and lymphatic system disorders       
Febrile neutropenia * 1  28/284 (9.86%)  0/92 (0.00%)  0/91 (0.00%) 
Neutropenia * 2  17/284 (5.99%)  0/92 (0.00%)  0/91 (0.00%) 
Leukopenia * 2  3/284 (1.06%)  0/92 (0.00%)  0/91 (0.00%) 
Anaemia * 2  2/284 (0.70%)  0/92 (0.00%)  0/91 (0.00%) 
Thrombocytopenia * 2  0/284 (0.00%)  0/92 (0.00%)  1/91 (1.10%) 
Cardiac disorders       
Myocardial infarction * 2  0/284 (0.00%)  0/92 (0.00%)  2/91 (2.20%) 
Arrhythmia * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Atrial fibrillation * 1  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Coronary artery disease * 2  0/284 (0.00%)  0/92 (0.00%)  1/91 (1.10%) 
Left ventricular dysfunction * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Ear and labyrinth disorders       
Vertigo * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Gastrointestinal disorders       
Intestinal perforation * 1  2/284 (0.70%)  0/92 (0.00%)  0/91 (0.00%) 
Large intestine perforation * 2  2/284 (0.70%)  0/92 (0.00%)  0/91 (0.00%) 
Intestinal obstruction * 2  1/284 (0.35%)  1/92 (1.09%)  0/91 (0.00%) 
Colitis * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Diverticular perforation * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Dysphagia * 2  0/284 (0.00%)  0/92 (0.00%)  1/91 (1.10%) 
Gastric haemorrhage * 2  0/284 (0.00%)  1/92 (1.09%)  0/91 (0.00%) 
Gastritis * 2  0/284 (0.00%)  1/92 (1.09%)  0/91 (0.00%) 
Gastrointestinal ulcer haemorrhage * 2  0/284 (0.00%)  0/92 (0.00%)  1/91 (1.10%) 
Haematemesis * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Subileus * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Upper gastrointestinal haemorrhage * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
General disorders       
Mucosal inflammation * 1  4/284 (1.41%)  0/92 (0.00%)  0/91 (0.00%) 
Pyrexia * 2  3/284 (1.06%)  0/92 (0.00%)  0/91 (0.00%) 
Asthenia * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Death * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Ulcer * 2  0/284 (0.00%)  0/92 (0.00%)  1/91 (1.10%) 
Infections and infestations       
Pneumonia * 2  5/284 (1.76%)  1/92 (1.09%)  0/91 (0.00%) 
Gastroenteritis * 2  2/284 (0.70%)  2/92 (2.17%)  0/91 (0.00%) 
Cellulitis * 2  2/284 (0.70%)  0/92 (0.00%)  0/91 (0.00%) 
Respiratory tract infection * 2  1/284 (0.35%)  0/92 (0.00%)  1/91 (1.10%) 
Urinary tract infection * 2  2/284 (0.70%)  0/92 (0.00%)  0/91 (0.00%) 
Gallbladder empyema * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Infection * 2  0/284 (0.00%)  0/92 (0.00%)  1/91 (1.10%) 
Meningitis * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Peritonitis * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Septic shock * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Upper respiratory tract infection * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Injury, poisoning and procedural complications       
Femur fracture * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Incisional hernia * 2  0/284 (0.00%)  0/92 (0.00%)  1/91 (1.10%) 
Toxicity to various agents * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Wound dehiscence * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Hypercalcaemia * 2  0/284 (0.00%)  1/92 (1.09%)  0/91 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Musculoskeletal pain * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Myalgia * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Large cell lung cancer * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Nervous system disorders       
Depressed level of consciousness * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
VIIth nerve paralysis * 2  0/284 (0.00%)  1/92 (1.09%)  0/91 (0.00%) 
Renal and urinary disorders       
Anuria * 2  0/284 (0.00%)  1/92 (1.09%)  0/91 (0.00%) 
Renal failure * 2  0/284 (0.00%)  1/92 (1.09%)  0/91 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea * 1  2/284 (0.70%)  0/92 (0.00%)  0/91 (0.00%) 
Epistaxis * 2  2/284 (0.70%)  0/92 (0.00%)  0/91 (0.00%) 
Pulmonary embolism * 2  2/284 (0.70%)  0/92 (0.00%)  0/91 (0.00%) 
Pleural effusion * 2  0/284 (0.00%)  1/92 (1.09%)  0/91 (0.00%) 
Respiratory distress * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Skin and subcutaneous tissue disorders       
Palmar-plantar erythrodysaesthesia syndrome * 2  0/284 (0.00%)  0/92 (0.00%)  1/91 (1.10%) 
Vascular disorders       
Embolism * 2  1/284 (0.35%)  1/92 (1.09%)  0/91 (0.00%) 
Embolism arterial * 2  1/284 (0.35%)  0/92 (0.00%)  0/91 (0.00%) 
Hypertension * 2  0/284 (0.00%)  0/92 (0.00%)  1/91 (1.10%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v.16.0)
2
Term from vocabulary, MedDRA v.16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Initial Treatment Phase:Bevacizumab + Docetaxel Maintenance Phase:Bevacizumab Maintenance Phase: Bevacizumab + Capecitabine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   40/284 (14.08%)   4/92 (4.35%)   32/91 (35.16%) 
Blood and lymphatic system disorders       
Neutropenia * 2  29/284 (10.21%)  1/92 (1.09%)  2/91 (2.20%) 
Skin and subcutaneous tissue disorders       
Palmar-plantar erythrodysaesthesia syndrome * 1  6/284 (2.11%)  0/92 (0.00%)  29/91 (31.87%) 
Vascular disorders       
Hypertension * 2  5/284 (1.76%)  3/92 (3.26%)  7/91 (7.69%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v.16.0)
2
Term from vocabulary, MedDRA v.16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann- LaRoche
Phone: 1-800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00929240    
Other Study ID Numbers: MO22223
2008-006872-31
First Submitted: June 16, 2009
First Posted: June 26, 2009
Results First Submitted: February 5, 2015
Results First Posted: March 3, 2015
Last Update Posted: March 3, 2015