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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. The anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 individuals.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Bevacizumab; Fluorouracil; Irinotecan; Oxaliplatin

Criteria

Inclusion Criteria:

• Previously untreated metastatic colon or rectal cancer

• Scheduled to begin IV 5-fluorouracil-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 prior to study start

• Treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment