Phase I Study to Evaluate the Combination Chemotherapy Regimen of Oxaliplatin Plus Irinotecan in Previously Treated Patients With Metastatic Gastrointestinal Cancer
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) for the combination chemotherapy
regimen of oxaliplatin plus irinotecan when both drugs are given once a week for four weeks,
followed by a two week rest, in patients with metastatic gastrointestinal cancer. II.
Evaluate the toxicities of this combination chemotherapy when administered in this manner.
III. Determine the pharmacokinetics of platinum and irinotecan at the MTD for this
combination chemotherapy in this patient population.
OUTLINE: This is a dose escalation study. Patients receive oxaliplatin IV over 120 minutes,
immediately followed by irinotecan IV over 30 minutes, weekly for 4 weeks (days 1, 8, 15,
and 22). Courses are repeated every 42 days. Treatment continues in the absence of
unacceptable side effects or disease progression. Sequential dose escalation of oxaliplatin
is followed by sequential dose escalation of irinotecan. Dose escalation in cohorts of 3-6
patients each continues until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose
limiting toxic effects. Patients are followed approximately every 2-3 months.
PROJECTED ACCRUAL: A total of 2-36 patients will be accrued for this study within 18-36
Primary Purpose: Treatment
Nancy E. Kemeny, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|