Status:
TERMINATED
Study of Oxaliplatin, Capecitabine, and Bevacizumab to Treat Older Patients With Colorectal Cancer
Lead Sponsor:
Geriatric Oncology Consortium
Collaborating Sponsors:
Sanofi
Conditions:
Colorectal Cancer
Neoplasm Metastasis
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief 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 wil...
Detailed Description
Colorectal cancer is primarily a disease of the elderly, with the median age in the United States of 70 years. Age greater than 65 years at presentation is not a contraindication to standard therapies...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00120172
Start Date
May 1 2005
End Date
June 1 2006
Last Update
November 16 2007
Active Locations (5)
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1
Mission Hills, California, United States, 91345
2
Washington D.C., District of Columbia, United States, 20007
3
Inverness, Florida, United States, 34452
4
New Port Richey, Florida, United States, 34652