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

An Expanded Access Program of AvastinTM (Bevacizumab) in Patients With Metastatic Cancer of the Colon or Rectum

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.

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