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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Bevacizumab

Criteria

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.