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A Study of Avastin (Bevacizumab) Combined With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum

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ClinicalTrials.gov Identifier: NCT01181609
Recruitment Status : Completed
First Posted : August 13, 2010
Results First Posted : July 28, 2014
Last Update Posted : July 28, 2014
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Intervention Drug: bevacizumab [Avastin]
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bevacizumab + Chemotherapy
Hide Arm/Group Description Participants received bevacizumab 2.5 milligrams per kilogram (mg/kg) intravenously (IV) per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
Period Title: Overall Study
Started 54
Completed 1
Not Completed 53
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             1
Lost to Follow-up             1
Death             50
Arm/Group Title Bevacizumab + Chemotherapy
Hide Arm/Group Description Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
Overall Number of Baseline Participants 53
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population: included participants who received at least 1 dose of treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants
60.2  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants
Female
18
  34.0%
Male
35
  66.0%
1.Primary Outcome
Title Percentage of Participants Achieving Overall Disease Control (ODC)
Hide Description ODC was defined as the percentage of participants with measurable disease at baseline who on assessment achieved complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since start of treatment. CR and PR were confirmed no less than 4 weeks after the criteria for response were met.
Time Frame Baseline, after every other cycle to disease progression or death (Maximum of 52.5 months follow-up)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab + Chemotherapy
Hide Arm/Group Description:
Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
Overall Number of Participants Analyzed 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
87
(77 to 97)
2.Secondary Outcome
Title Percentage of Participants Achieving a Best Overall Response of CR or PR
Hide Description Percentage of participants achieving CR or PR as defined by RECIST criteria. CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as ≥30% decrease under baseline of the sum of the LD of all target lesions. CR and PR were confirmed no less than 4 weeks after the criteria for response were met.
Time Frame Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab + Chemotherapy
Hide Arm/Group Description:
Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
Overall Number of Participants Analyzed 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
32
(19 to 46)
3.Secondary Outcome
Title Progression-Free Survival (PFS) - Percentage of Participants With an Event
Hide Description PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST.
Time Frame Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Bevacizumab + Chemotherapy
Hide Arm/Group Description:
Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
Overall Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: percentage of participants
98
4.Secondary Outcome
Title PFS - Time to Event
Hide Description PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST. Median PFS was estimed using the Kaplan-Meier method.
Time Frame Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab + Chemotherapy
Hide Arm/Group Description:
Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
Overall Number of Participants Analyzed 53
Median (95% Confidence Interval)
Unit of Measure: months
6.5
(5.8 to 7.8)
5.Secondary Outcome
Title Duration of Response
Hide Description Duration of response was defined as the time in months from the day of CR or PR was first noted to the day of progression of disease, death or last follow-up. Median duraiton of response is estimated sing the Kaplan-Meier method.
Time Frame Baseline, every cycle until progression or death (Maximum of 52.5 months follow-up)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population; only participants with a response (CR or PR) were included in the analysis.
Arm/Group Title Bevacizumab + Chemotherapy
Hide Arm/Group Description:
Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
Overall Number of Participants Analyzed 17
Median (95% Confidence Interval)
Unit of Measure: months
6
(4.8 to 7.5)
6.Secondary Outcome
Title Duration of Overall Disease Control
Hide Description ODC duration was defined as the time in months, from when measurement criteria were first met for CR, PR, or SD (whichever status was recorded first) until the first date when progressive disease or the death from any cause was documented. Data were censored for participants who were lost to follow-up, discontinued prematurely without progression/death, or who reached the end of study without progression. Median ODC was estimated using the Kaplan-Meier method.
Time Frame Baseline, every cycle until progression or death. (Maximum of 52.5 months follow-up)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population; only participants with an ODC response (CR, PR, or SD) were included in the analysis.
Arm/Group Title Bevacizumab + Chemotherapy
Hide Arm/Group Description:
Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
Overall Number of Participants Analyzed 46
Median (95% Confidence Interval)
Unit of Measure: months
6.7
(5.2 to 7.1)
7.Secondary Outcome
Title Overall Survival (OS) - Percentage of Participants With an Event
Hide Description Overall survival was defined as the time from start of study treatment to death from any cause.
Time Frame Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab + Chemotherapy
Hide Arm/Group Description:
Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
Overall Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: percentage of participants
93.0
8.Secondary Outcome
Title OS - Time to Event
Hide Description OS was defined as the time from start of study treatment to death from any cause. Median OS was estimated using the Kaplan-Meier method.
Time Frame Baseline, every cycle to progression or death. (Maximum of 52.5 months follow-up)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab + Chemotherapy
Hide Arm/Group Description:
Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
Overall Number of Participants Analyzed 53
Median (95% Confidence Interval)
Unit of Measure: months
19.3
(14.2 to 25.1)
Time Frame Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration.
Adverse Event Reporting Description All participants who received at least 1 dose of study treatment were included in the safety analysis population.
 
Arm/Group Title Bevacizumab + Chemotherapy
Hide Arm/Group Description Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
All-Cause Mortality
Bevacizumab + Chemotherapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab + Chemotherapy
Affected / at Risk (%)
Total   9/53 (16.98%) 
Blood and lymphatic system disorders   
Febrile neutropenia * 1  1/53 (1.89%) 
Gastrointestinal disorders   
Abdominal pain * 1  3/53 (5.66%) 
General disorders   
Hyperthermia * 1  1/53 (1.89%) 
Infections and infestations   
Gastroenteritis * 1  1/53 (1.89%) 
Injury, poisoning and procedural complications   
Humerus fracture * 1  1/53 (1.89%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/53 (1.89%) 
Psychiatric disorders   
Cholinergic syndrome * 1  1/53 (1.89%) 
Renal and urinary disorders   
Renal failure * 1  1/53 (1.89%) 
Renal pain * 1  1/53 (1.89%) 
Reproductive system and breast disorders   
Pelvic pain * 1  1/53 (1.89%) 
Surgical and medical procedures   
Inguinal hernia repair * 1  1/53 (1.89%) 
Radiofrequency ablation * 1  1/53 (1.89%) 
Colonoscopy * 1  1/53 (1.89%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, NCI CTC version 3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bevacizumab + Chemotherapy
Affected / at Risk (%)
Total   52/53 (98.11%) 
Blood and lymphatic system disorders   
Neutropenia * 1  16/53 (30.19%) 
Anemia * 1  7/53 (13.21%) 
Thrombocytopenia * 1  4/53 (7.55%) 
Eye disorders   
Eye disorder * 1  8/53 (15.09%) 
Gastrointestinal disorders   
Nausea * 1  35/53 (66.04%) 
Diarrhea * 1  32/53 (60.38%) 
Vomiting * 1  25/53 (47.17%) 
Abdominal pain * 1  13/53 (24.53%) 
Constipation * 1  12/53 (22.64%) 
Abdominal pain upper * 1  8/53 (15.09%) 
Aphthous stomatitis * 1  5/53 (9.43%) 
Dyspepsia * 1  5/53 (9.43%) 
Toothache * 1  4/53 (7.55%) 
Haemorrhoids * 1  3/53 (5.66%) 
Gastro-intestinal perforation * 1  0/53 (0.00%) 
General disorders   
Asthenia * 1  32/53 (60.38%) 
Mucosal inflammation * 1  18/53 (33.96%) 
Fatigue * 1  6/53 (11.32%) 
Pyrexia * 1  5/53 (9.43%) 
Hepatobiliary disorders   
Hepatobiliary disorders * 1  3/53 (5.66%) 
Infections and infestations   
Gastroenteritis * 1  5/53 (9.43%) 
Rhinitis * 1  4/53 (7.55%) 
Nasopharyngitis * 1  3/53 (5.66%) 
Injury, poisoning and procedural complications   
Injury, poisoning and procedural complications * 1  4/53 (7.55%) 
Wound healing complication * 1  1/53 (1.89%) 
Investigations   
Weight decreased * 1  4/53 (7.55%) 
Metabolism and nutrition disorders   
Anorexia * 1  13/53 (24.53%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  4/53 (7.55%) 
Pain in extremity * 1  5/53 (9.43%) 
Musculoskeletal stiffness * 1  3/53 (5.66%) 
Myalgia * 1  3/53 (5.66%) 
Nervous system disorders   
Paresthesia * 1  13/53 (24.53%) 
Headache * 1  8/53 (15.09%) 
Neuropathy * 1  5/53 (9.43%) 
Dizziness * 1  4/53 (7.55%) 
Psychiatric disorders   
Anxiety * 1  5/53 (9.43%) 
Renal and urinary disorders   
Renal and urinary disorders * 1  3/53 (5.66%) 
Proteinuria * 1  6/53 (11.32%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  3/53 (5.66%) 
Dyspnea * 1  3/53 (5.66%) 
Bleeding/hemorrhage (all epistaxis) * 1  29/53 (54.72%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  18/53 (33.96%) 
Palmar-plantar erythrodysesthesia syndrome * 1  6/53 (11.32%) 
Surgical and medical procedures   
Surgical and medical procedures * 1  5/53 (9.43%) 
Vascular disorders   
Vascular disorders * 1  3/53 (5.66%) 
Hypertension * 1  22/53 (41.51%) 
Thromboembolism * 1  3/53 (5.66%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, NCI CTC version 3.0
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 only after the first publication or presentation that involves the Overall Study. The Sponsor may request the Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
Phone: 800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01181609     History of Changes
Other Study ID Numbers: ML18559
First Submitted: July 30, 2010
First Posted: August 13, 2010
Results First Submitted: June 4, 2014
Results First Posted: July 28, 2014
Last Update Posted: July 28, 2014