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An Observational Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) And Oxaliplatin in Patients With Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT01399190
Recruitment Status : Completed
First Posted : July 21, 2011
Results First Posted : September 28, 2016
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Colorectal Cancer
Interventions Biological: Bevacizumab
Biological: Capecitabine
Drug: Oxaliplatin
Enrollment 68
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bevacizumab
Hide Arm/Group Description Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
Period Title: Overall Study
Started 68
Included in Final Analysis 63
Evaluable for Primary Endpoint Analysis 60
Completed 48
Not Completed 20
Reason Not Completed
Not Eligible for Final Analysis             5
Adverse Event             8
Participant's Request             5
Physician Decision             2
Arm/Group Title Bevacizumab
Hide Arm/Group Description Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
Overall Number of Baseline Participants 63
Hide Baseline Analysis Population Description
Includes enrolled participants eligible for inclusion in the final analysis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants
60.08  (10.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
Female
29
  46.0%
Male
34
  54.0%
1.Primary Outcome
Title Progression-free Survival
Hide Description Progression-free survival was defined as the interval between the day of first treatment and the first documentation of disease progression or death and was assessed by the investigators according to modified Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was defined as an increase in sum of lesions size by more than 20% or new lesions.
Time Frame From randomization to progression or death during the study (up to approximately 30 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Includes enrolled participants who were evaluable for the primary endpoint analysis.
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
Overall Number of Participants Analyzed 60
Median (95% Confidence Interval)
Unit of Measure: months
7.000
(5.577 to 8.423)
2.Secondary Outcome
Title Response Rate (Tumor Assessments According to RECIST)
Hide Description Response to treatment (Response Rate) was defined as the percentage of participants with a complete remission (CR) or partial remission (PR), and was assessed by the investigators according to modified RECIST criteria. CR was defined as disappearance of all lesions. PR was defined as a decrease in sum of lesions size by more than 30%. Response Rate = CR +PR
Time Frame Up to approximately 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes enrolled participants who were evaluable for the primary endpoint analysis.
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: percentage of participants
Response Rate 48.4
Complete remission 6.7
Partial remission 41.7
3.Secondary Outcome
Title Percentage of Participants With Adverse Events
Hide Description An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame Up to approximately 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes enrolled participants eligible for inclusion in the final analysis.
Arm/Group Title Bevacizumab
Hide Arm/Group Description:
Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
Overall Number of Participants Analyzed 63
Measure Type: Number
Unit of Measure: percentage of participants
74.6
Time Frame Up to approximately 30 months
Adverse Event Reporting Description Includes enrolled participants eligible for inclusion in the final analysis.
 
Arm/Group Title Bevacizumab
Hide Arm/Group Description Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
All-Cause Mortality
Bevacizumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab
Affected / at Risk (%)
Total   2/63 (3.17%) 
Cardiac disorders   
Atrioventricular block  1  1/63 (1.59%) 
Vascular disorders   
Hypertensive crisis  1  1/63 (1.59%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bevacizumab
Affected / at Risk (%)
Total   39/63 (61.90%) 
Blood and lymphatic system disorders   
Thrombocytopenia  1  13/63 (20.63%) 
Anaemia  1  4/63 (6.35%) 
Gastrointestinal disorders   
Diarrhoea  1  4/63 (6.35%) 
Immune system disorders   
Allergic reaction  1  6/63 (9.52%) 
Nervous system disorders   
Neuropathy peripheral  1  23/63 (36.51%) 
Skin and subcutaneous tissue disorders   
Palmar-plantar erythrodysesthesia syndrome  1  4/63 (6.35%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
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 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-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01399190     History of Changes
Other Study ID Numbers: ML25523
First Submitted: July 20, 2011
First Posted: July 21, 2011
Results First Submitted: August 4, 2016
Results First Posted: September 28, 2016
Last Update Posted: September 28, 2016