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A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum.

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 22, 2010
Last updated: August 25, 2016
Last verified: February 2016
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.

Condition Intervention Phase
Colorectal Cancer
Drug: Bevacizumab
Drug: Fluoropyrimidine-based Chemotherapy
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: First-Line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum First BEAT (Bevacizumab Expanded Access Trial)- Brazilian Extension

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Number of Participants With Serious and Specific Adverse Events [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
    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.

Secondary Outcome Measures:
  • Efficacy: Overall Survival [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
    Overall survival was measured as the time from start of first bevacizumab administration to death. For participants who were alive at the end of the study, data on survival were censored at the time of the last contact. Reported is the median duration of overall survival.

  • Efficacy: Time to Disease Progression [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
    Time to disease progression was measured as the time from start of first bevacizumab administration to investigator-assessed progression. For participants without disease progression at the end of the study, date and time to progression were censored at the last investigator assessment. Reported is the median time to disease progression.

  • Efficacy: Progression-free Survival [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
    Progression-free survival (PFS) was measured as the time from start of first bevacizumab administration to investigator-assessed progression or death, whichever occurred first. Reported is the median time of PFS.

Enrollment: 168
Study Start Date: May 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab
Bevacizumab 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.
Drug: Bevacizumab
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.
Other Name: Avastin
Drug: Fluoropyrimidine-based Chemotherapy
Fluoropyrimidine-based chemotherapy administered according to standard of care.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Previously untreated metastatic colon or rectal cancer;
  • Scheduled to begin fluoropyrimidine-based chemotherapy as a first line treatment.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01169558

Belo Horizonte, Brazil, 30140-083
Belo Horizonte, Brazil, 30150-221
Belo Horizonte, Brazil, 30150321
Brasilia, Brazil, 70390-150
Brasilia, Brazil, 70710-904
Campinas, Brazil, 13073-400
Campinas, Brazil, 13084-759
Caxias Do Sul, Brazil, 95020-450
Curitiba, Brazil, 80530-010
Curitiba, Brazil, 80730-180
Fortaleza, Brazil, 60741-420
Ijui, Brazil, 98700-000
Joao Pessoa, Brazil, 58040280
Porto Alegre, Brazil, 90020-090
Porto Alegre, Brazil, 90035-903
Recife, Brazil, 52012-220
Ribeirao Preto, Brazil, 14025-430
Rio de Janeiro, Brazil, 22031072
Rio de Janeiro, Brazil, 22631-004
Salvador, Brazil, 40170-110
Salvador, Brazil, 41810-012
Salvador, Brazil, 41950-610
Sao Paulo, Brazil, 01229-000
Sao Paulo, Brazil, 01232-010
Sao Paulo, Brazil, 01332-000
Sao Paulo, Brazil, 01406100
Sao Paulo, Brazil, 04122-000
Sao Paulo, Brazil, 05651-901
Sponsors and Collaborators
Hoffmann-La Roche
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01169558     History of Changes
Other Study ID Numbers: ML20552 
Study First Received: July 22, 2010
Results First Received: August 25, 2016
Last Updated: August 25, 2016
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents processed this record on October 21, 2016