Phase I and Pharmacokinetic Study of Sequentially Administered CPT-11 and Mitomycin C in Patients With Advanced Solid Tumors
OBJECTIVES: I. Determine the maximum tolerated dose of mitomycin when administered with
irinotecan in patients with advanced solid tumors. II. Determine whether the pharmacokinetic
profile of irinotecan is altered by prior administration of mitomycin in this patient
population. III. Determine the effect of irinotecan and mitomycin on the expression of
DT-Diaphorase and the Topo I gene. IV. Determine the preliminary antitumor activity of this
regimen in these patients.
OUTLINE: This is a dose escalation study. Patients receive mitomycin IV over 20 to 30
minutes on day 1 and irinotecan IV over 90 minutes on days 2, 8, 15, and 22, followed by 2
weeks of rest beginning on day 29. Treatment continues every 6 weeks in the absence of
disease progression or unacceptable toxicity. Cohorts of 3 to 6 patients each receive
escalating doses of mitomycin and irinotecan until the maximum tolerated dose (MTD) is
reached. The MTD is defined as the dose at which no more than 1 of 6 patients experiences
dose limiting toxicity. Patients are followed for 1 month.
PROJECTED ACCRUAL: Up to 30 patients will be accrued for this study.
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Ronald L. Drengler, MD
South Texas Oncology and Hematology - Wurzbach Road
United States: Food and Drug Administration
|San Antonio Cancer Institute||San Antonio, Texas 78229-3264|