A Phase I Study of Oxaliplatin in Combination With Capecitabine in Metastatic/Recurrent Solid Tumors
OBJECTIVES: I. Determine the maximum tolerated dose of capecitabine when administered in
combination with oxaliplatin in patients with metastatic or recurrent solid tumors. II.
Determine the toxicities of this treatment regimen in this patient population.
OUTLINE: This is a dose escalation study of capecitabine. Patients receive oxaliplatin IV
over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats
every 2 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6
patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
experience dose limiting toxicity. Patients are followed for disease progression and
PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study.
Primary Purpose: Treatment
Heinz-Josef Lenz, MD
USC/Norris Comprehensive Cancer Center
United States: Federal Government
|USC/Norris Comprehensive Cancer Center||Los Angeles, California 90033-0800|
|Beckman Research Institute, City of Hope||Los Angeles, California 91010|
|University of California Davis Cancer Center||Sacramento, California 95817|