Study of Oxaliplatin, Capecitabine, and Bevacizumab to Treat Older Patients With Colorectal Cancer

• Status: Terminated
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Currently there is no one standard of care for older patients with metastatic colorectal cancer. The study will examine the tumor response to capecitabine, oxaliplatin, plus bevacizumab. The study will also gather information on the usefulness and side effects of this treatment combination.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Geriatric Oncology Consortium
• Collaborator: Sanofi
• Treatments: Bevacizumab; Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• Age 65 years and above;

• Histologically or cytologically documented adenocarcinoma of the colon or rectum;

• Metastatic disease;

• Measurable disease or assessable but nonmeasurable disease allowed;

• ECOG 0-1

• No prior oxaliplatin or bevacizumab.

• No prior chemotherapy for metastatic disease. Prior adjuvant chemotherapy allowed;

• No prior fluoropyrimidine therapy (unless give in an adjuvant setting and completed at least 4 months earlier);

• No bleeding diathesis or coagulopathy

• Adequate renal and hepatic functions as per protocol;

• Signed informed consent

Exclusion Criteria:

• Clinically significant cardiovascular or peripheral vascular disease;

• Concurrent chronic aspirin, nonsteroidal anti-inflammatory drugs, warfarin, or therapeutic heparin;

• Serious non-healing wound, ulcer, or bone fracture;