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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Bevacizumab; Drug: Fluoropyrimidine-based Chemotherapy

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • 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, 41950-610
  • Salvador, Brazil, 40170-110
  • Salvador, Brazil, 41810-012
  • Sao Paulo, Brazil, 01232-010
  • Sao Paulo, Brazil, 01332-000
  • Sao Paulo, Brazil, 01406100
  • Sao Paulo, Brazil, 05651-901
  • Sao Paulo, Brazil, 01229-000
  • Sao Paulo, Brazil, 04122-000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Avastin; Drug: Fluoropyrimidine-based Chemotherapy; Fluoropyrimidine-based chemotherapy administered according to standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: Overall Survival	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.	Up to approximately 3 years
Efficacy: Time to Disease Progression	Time to disease progression was measured as the time from start of first bevacizumab administration to investigator-assessed progression. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. 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.	Up to approximately 3 years
Efficacy: Progression-free Survival	Progression-free survival (PFS) was measured as the time from start of first bevacizumab administration to investigator-assessed progression or death, whichever occurred first. Progression was defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Reported is the median time of PFS.	Up to approximately 3 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: July 22, 2010
• First Submitted That Met QC Criteria: July 23, 2010
• First Posted (Estimate): July 26, 2010

Study Record Updates

• Last Update Posted (Estimate): December 8, 2016
• Last Update Submitted That Met QC Criteria: October 26, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis; Colonic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: ML20552