A Phase I Study of Oxaliplatin in Combination With Gemcitabine
OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicities of
gemcitabine in combination with oxaliplatin in patients with advanced malignancies. II.
Determine the pharmacokinetics of oxaliplatin and gemcitabine in these patients.
OUTLINE: This is a multicenter, dose escalation study of gemcitabine. Patients receive
oxaliplatin IV over 2 hours on day 1 and gemcitabine IV over 30 minutes on days 1 and 8.
Treatment continues every 3 weeks in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine in combination
with a fixed dose of oxaliplatin until the maximum tolerated dose (MTD) is determined. The
MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting
PROJECTED ACCRUAL: A total of 24-36 patients will be accrued for this study within 2 years.
Primary Purpose: Treatment
Stephen I. Shibata, MD
Beckman Research Institute
United States: Federal Government
|Cancer Center and Beckman Research Institute, City of Hope||Duarte, California 91010-3000|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|University of California Davis Cancer Center||Sacramento, California 95817|