A Phase II Study of Oxaliplatin, Capecitabine, and Bevacizumab in the Treatment of Elderly Patients With Metastatic Colorectal Cancer
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the efficacy (measured by time to progression) of oxaliplatin, capecitabine, and bevacizumab as first-line therapy in elderly patients with metastatic colorectal cancer.
Stuart Lichtman, MD
Study Chair
Geriatric Oncology Consortium
United States: Institutional Review Board
GOC-GI-010
NCT00120172
May 2005
June 2006
Name | Location |
---|---|
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Washington, District of Columbia | |
Coeur D'alene, Idaho 83814 |