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

Stopped early · Phase 2

Conditions studied: Colorectal Cancer, Neoplasm Metastasis

In brief

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.

Key facts

Study ID

NCT00120172

Run by

Geriatric Oncology Consortium

People needed

40

Starts

2005-05-01

Expected to finish

2006-06-01

Last updated by the study team

2007-11-16

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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;

Where it is running

• Study site — Mission Hills, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Inverness, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — Coeur d'Alene, Idaho, United States

Full record on ClinicalTrials.gov

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