Back to resultsA Study of Avastin (Bevacizumab) Combined With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
bevacizumab [Avastin]
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with metastatic colon or rectal cancer, progressing or relapsing after first-line treatment;
- Women of childbearing potential must use adequate contraception up to at least 6 months after the last dose of bevacizumab.
Exclusion Criteria:
- Patients with metastatic colon or rectal cancer scheduled for a first-line systemic treatment;
- Untreated brain metastases, spinal cord compression or primary brain tumours;
- Pregnant or lactating women;
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study start;
- Treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving Overall Disease Control (ODC)
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.
Secondary Outcome Measures
Percentage of Participants Achieving a Best Overall Response of CR or PR
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.
Progression-Free Survival (PFS) - Percentage of Participants With an Event
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.
PFS - Time to Event
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.
Duration of Response
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.
Duration of Overall Disease Control
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.
Overall Survival (OS) - Percentage of Participants With an Event
Overall survival was defined as the time from start of study treatment to death from any cause.
OS - Time to Event
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01181609
Brief Title
A Study of Avastin (Bevacizumab) Combined With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum
Official Title
An Open-label Study of Avastin in Combination With Chemotherapy Regimens as Second-line Treatment in Patients With Metastatic Colon or Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This study will assess the efficacy and safety of intravenous Avastin in combination with chemotherapy regimens as second-line treatment of metastatic cancer of the colon or rectum. The anticipated time of study treatment is until disease progression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bevacizumab [Avastin]
Intervention Description
5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks according to the chemotherapy regimen
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Overall Disease Control (ODC)
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)
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving a Best Overall Response of CR or PR
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)
Title
Progression-Free Survival (PFS) - Percentage of Participants With an Event
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)
Title
PFS - Time to Event
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)
Title
Duration of Response
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)
Title
Duration of Overall Disease Control
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)
Title
Overall Survival (OS) - Percentage of Participants With an Event
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)
Title
OS - Time to Event
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with metastatic colon or rectal cancer, progressing or relapsing after first-line treatment;
Women of childbearing potential must use adequate contraception up to at least 6 months after the last dose of bevacizumab.
Exclusion Criteria:
Patients with metastatic colon or rectal cancer scheduled for a first-line systemic treatment;
Untreated brain metastases, spinal cord compression or primary brain tumours;
Pregnant or lactating women;
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study start;
Treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Angers
ZIP/Postal Code
49933
Country
France
City
Besancon
ZIP/Postal Code
25030
Country
France
City
Boulogne-billancourt
ZIP/Postal Code
92104
Country
France
City
Colmar
ZIP/Postal Code
68024
Country
France
City
Dijon
ZIP/Postal Code
21079
Country
France
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
City
Marseille
ZIP/Postal Code
13005
Country
France
City
Montpellier
ZIP/Postal Code
34298
Country
France
City
Neuilly Sur Seine
ZIP/Postal Code
92200
Country
France
City
Nice
ZIP/Postal Code
06189
Country
France
City
Paris
ZIP/Postal Code
75679
Country
France
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
City
Reims
ZIP/Postal Code
51092
Country
France
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
City
Saint-cloud
ZIP/Postal Code
92210
Country
France
City
Toulouse
ZIP/Postal Code
31052
Country
France
12. IPD Sharing Statement
Learn more about this trial
A Study of Avastin (Bevacizumab) Combined With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum
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