A Phase I Study of Oxaliplatin, CPT-11, 5-FU and Leucovorin in Patients With Solid Tumors
OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan, fluorouracil, and
leucovorin calcium (Saltz regimen vs Mayo regimen) plus oxaliplatin (arm I vs arm II) in
patients with metastatic or unresectable solid tumors. II. Determine the effect of
irinotecan on the disposition of oxaliplatin in these patients. III. Assess the development
of peripheral neuropathy in these patients on the Mayo regimen. IV. Determine the activity
of these regimens in patients with metastatic solid tumors.
OUTLINE: This is a dose escalation study. Patients are entered to one of two treatment arms:
Arm I (Saltz regimen): Patients receive irinotecan IV over 90 minutes, leucovorin calcium
IV, and fluorouracil IV on days 1, 8, 15, and 22, followed by oxaliplatin IV over 2 hours on
days 1 and 15. Courses repeat every 6 weeks. Arm II (Mayo regimen): Patients receive
irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1, followed by
leucovorin calcium IV and fluorouracil IV over 90 minutes on days 2-5. Courses repeat every
3 weeks. Cohorts of 3-6 patients receive escalating doses of fluorouracil (one of two
treatment doses for arm II), and one of two treatment doses of irinotecan and oxaliplatin
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 3 months.
PROJECTED ACCRUAL: Up to 60 patients will be accrued for this study within 8-14 months.
Primary Purpose: Treatment
Richard M. Goldberg, MD
United States: Federal Government
|Mayo Clinic||Rochester, Minnesota 55905|