A Study of Avastin (Bevacizumab) Combined With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum
An Open-label Study of Avastin in Combination With Chemotherapy Regimens as Second-line Treatment in Patients With Metastatic Colon or Rectal Cancer
1 other identifier
interventional
54
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 colorectal-cancer
Started Jun 2005
Typical duration for phase_2 colorectal-cancer
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 30, 2010
CompletedFirst Posted
Study publicly available on registry
August 13, 2010
CompletedResults Posted
Study results publicly available
July 28, 2014
CompletedJuly 28, 2014
July 1, 2014
4.9 years
July 30, 2010
June 4, 2014
July 24, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline, after every other cycle to disease progression or death (Maximum of 52.5 months follow-up)
Secondary Outcomes (7)
Percentage of Participants Achieving a Best Overall Response of CR or PR
Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)
Progression-Free Survival (PFS) - Percentage of Participants With an Event
Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)
PFS - Time to Event
Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)
Duration of Response
Baseline, every cycle until progression or death (Maximum of 52.5 months follow-up)
Duration of Overall Disease Control
Baseline, every cycle until progression or death. (Maximum of 52.5 months follow-up)
- +2 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALInterventions
5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks according to the chemotherapy regimen
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Unknown Facility
Angers, 49933, France
Unknown Facility
Besançon, 25030, France
Unknown Facility
Boulogne-Billancourt, 92104, France
Unknown Facility
Colmar, 68024, France
Unknown Facility
Dijon, 21079, France
Unknown Facility
La Roche-sur-Yon, 85925, France
Unknown Facility
Marseille, 13005, France
Unknown Facility
Montpellier, 34298, France
Unknown Facility
Neuilly-sur-Seine, 92200, France
Unknown Facility
Nice, 06189, France
Unknown Facility
Paris, 75679, France
Unknown Facility
Pierre-Bénite, 69310, France
Unknown Facility
Reims, 51092, France
Unknown Facility
Saint-Cloud, 92210, France
Unknown Facility
Saint-Herblain, 44805, France
Unknown Facility
Toulouse, 31052, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2010
First Posted
August 13, 2010
Study Start
June 1, 2005
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
July 28, 2014
Results First Posted
July 28, 2014
Record last verified: 2014-07