A Phase I Trial of Dose Escalated Irinotecan (CPT-11) With Paclitaxel in Patients With Metastatic or Recurrent Malignancies
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of irinotecan administered in
combination with paclitaxel in patients with metastatic or recurrent malignancies. II.
Evaluate the toxicity and safety of this combination regimen in this patient population.
III. Determine the pharmacokinetic profile of irinotecan in combination with paclitaxel on a
weekly schedule and if the sequence of administration influences irinotecan pharmacokinetics
in these patients. IV. Determine pharmacodynamic models of irinotecan and its SN-38 and
SN-38G metabolites when administered in this weekly combination schedule.
OUTLINE: This is a dose escalation study of irinotecan. Patients receive irinotecan IV
concurrently with paclitaxel IV weekly. Patients demonstrating stable disease or partial or
complete clinical response continue with treatment as long as dose limiting toxicities are
not observed and adequate performance status is maintained. Cohorts of 3 patients receive
escalating doses of irinotecan until the maximum tolerated dose is determined or 150 mg/m2
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the maximum tolerated dose
Determine the maximum tolerated dose of irinotecan administered on a weekly schedule with fixed-dose weekly paclitaxel.
Hedy L. Kindler, MD
University of Chicago
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|