A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum.
First-Line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum First BEAT (Bevacizumab Expanded Access Trial)- Brazilian Extension
1 other identifier
interventional
168
1 country
28
Brief Summary
This expanded access study will assess the safety and efficacy of intravenous bevacizumab (5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum. The anticipated time on study treatment is 3-12 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 colorectal-cancer
Started May 2006
28 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
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 22, 2010
CompletedFirst Posted
Study publicly available on registry
July 26, 2010
CompletedResults Posted
Study results publicly available
October 18, 2016
CompletedDecember 8, 2016
October 1, 2016
3.2 years
July 22, 2010
August 25, 2016
October 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Safety: Number of Participants With Serious and Specific Adverse Events
A serious adverse event was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. Specific adverse events (Spec AEs) included the following: hypertension, bleeding/hemorrhage, proteinuria, wound healing complications, thrombosis/thrombus/embolism (t/t/e), thrombosis/thrombus/embolism - vascular access, gastrointestinal perforation, and infusion (injection) site reaction.
Up to approximately 3 years
Secondary Outcomes (3)
Efficacy: Overall Survival
Up to approximately 3 years
Efficacy: Time to Disease Progression
Up to approximately 3 years
Efficacy: Progression-free Survival
Up to approximately 3 years
Study Arms (1)
Bevacizumab
EXPERIMENTALBevacizumab will be administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
Interventions
5 mg/kg bevacizumab administered intravenously every 2 weeks or 7.5 mg/kg bevacizumab administered intravenously every 3 weeks according to the standard chemotherapy regimen.
Fluoropyrimidine-based chemotherapy administered according to standard of care.
Eligibility Criteria
You may qualify if:
- Previously untreated metastatic colon or rectal cancer;
- Scheduled to begin fluoropyrimidine-based chemotherapy as a first line treatment.
You may not qualify if:
- Prior chemotherapy for metastatic colon or rectal cancer;
- Planned radiotherapy for underlying disease;
- central nervous system metastases;
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before study start.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Unknown Facility
Belo Horizonte, 30140-083, Brazil
Unknown Facility
Belo Horizonte, 30150-221, Brazil
Unknown Facility
Belo Horizonte, 30150321, Brazil
Unknown Facility
Brasília, 70390-150, Brazil
Unknown Facility
Brasília, 70710-904, Brazil
Unknown Facility
Campinas, 13073-400, Brazil
Unknown Facility
Campinas, 13084-759, Brazil
Unknown Facility
Caxias do Sul, 95020-450, Brazil
Unknown Facility
Curitiba, 80530-010, Brazil
Unknown Facility
Curitiba, 80730-180, Brazil
Unknown Facility
Fortaleza, 60741-420, Brazil
Unknown Facility
Ijuí, 98700-000, Brazil
Unknown Facility
João Pessoa, 58040280, Brazil
Unknown Facility
Porto Alegre, 90020-090, Brazil
Unknown Facility
Porto Alegre, 90035-903, Brazil
Unknown Facility
Recife, 52012-220, Brazil
Unknown Facility
Ribeirão Preto, 14025-430, Brazil
Unknown Facility
Rio de Janeiro, 22031072, Brazil
Unknown Facility
Rio de Janeiro, 22631-004, Brazil
Unknown Facility
Salvador, 40170-110, Brazil
Unknown Facility
Salvador, 41810-012, Brazil
Unknown Facility
Salvador, 41950-610, Brazil
Unknown Facility
São Paulo, 01229-000, Brazil
Unknown Facility
São Paulo, 01232-010, Brazil
Unknown Facility
São Paulo, 01332-000, Brazil
Unknown Facility
São Paulo, 01406100, Brazil
Unknown Facility
São Paulo, 04122-000, Brazil
Unknown Facility
São Paulo, 05651-901, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
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 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2010
First Posted
July 26, 2010
Study Start
May 1, 2006
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
December 8, 2016
Results First Posted
October 18, 2016
Record last verified: 2016-10