Phase I Study of Oxaliplatin in Combination With 5-Fluorouracil and Gemcitabine in Patients With Solid Tumors
I. Determine the maximum tolerated dose, recommended phase II dose, and associated toxic
effects of the triple combination of continuous infusion fluorouracil, weekly gemcitabine,
and oxaliplatin in patients with metastatic or unresectable solid tumors.
II. Define sequence dependent toxic effects, if any, and establish pharmacokinetic and
pharmacodynamic relationships in context of this triple combination chemotherapy in this
OUTLINE: This is a dose-escalation study of oxaliplatin and gemcitabine.
For course 1, and then course 3 and beyond, patients receive oxaliplatin IV over 2 hours on
day 1, followed by gemcitabine IV over 30 minutes on days 1 and 8, and then fluorouracil IV
continuously on days 1-14. For course 2, patients receive treatment in the same manner as in
course 1, except gemcitabine is given initially, followed by oxaliplatin, and then
fluorouracil. Treatment continues every 21 days in the absence of unacceptable toxicity or
Cohorts of 1-6 patients receive escalating doses of oxaliplatin and gemcitabine 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. The recommended phase II dose
(RPTD) is defined as the dose preceding MTD.
Once RPTD is defined, the cohort is expanded to an additional 13 patients. These patients
receive a fixed dose of oxaliplatin, gemcitabine, and fluorouracil as determined by the
phase I dose escalation portion of this study.
Patients are followed for disease progression.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Howard S. Hochster, MD
New York University School of Medicine
United States: Federal Government
|Albert Einstein Comprehensive Cancer Center||Bronx, New York 10461|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center||New York, New York 10016|