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

NCT ID: NCT00120172

Last Updated: 2007-11-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2006-06-30

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 will also gather information on the usefulness and side effects of this treatment combination.

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; acceptable morbidity and mortality, as well as long term survival, are achieved in this patient population. However, studies evaluating combination therapy have generally involved younger patients with high performance status scores. Given the non-over-lapping safety profiles of the proposed study agents and the potential synergy, it would be of benefit to explore the combination of oxaliplatin, capecitabine, and bevacizumab in the treatment of older patients with colorectal cancer. Time to progression, overall response, duration of response, and toxicity profile will be evaluated. The feasibility of using a self-report geriatric assessment tool will also be assessed.

Conditions

Colorectal Cancer; Neoplasm Metastasis

Keywords

colorectal; metastatic; elderly; metastatic colorectal cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

oxaliplatin, capecitabine, bevacizumab

Intervention Type: DRUG

Eligibility 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;

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Geriatric Oncology Consortium

OTHER

Sponsor Role: lead

Principal Investigators

Stuart Lichtman, MD

Role: STUDY_CHAIR

Geriatric Oncology Consortium

Locations

Mission Hills, California, United States

Washington D.C., District of Columbia, United States

Inverness, Florida, United States

New Port Richey, Florida, United States

Coeur d'Alene, Idaho, United States

Countries

United States

Other Identifiers

GOC-GI-010

Identifier Type: -

Identifier Source: org_study_id