Irinotecan Plus Mitomycin in Treating Patients With Advanced Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of irinotecan plus mitomycin in treating patients who have advanced solid tumors that are persistent or recurrent.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: irinotecan hydrochloride Drug: mitomycin C||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I and Pharmacokinetic Study of Sequentially Administered CPT-11 and Mitomycin C in Patients With Advanced Solid Tumors|
|Study Start Date:||August 1998|
|Study Completion Date:||May 2001|
|Primary Completion Date:||May 2001 (Final data collection date for primary outcome measure)|
Drug: irinotecan hydrochloride
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003710
|United States, Texas|
|San Antonio Cancer Institute|
|San Antonio, Texas, United States, 78229|
|Study Chair:||Ronald L. Drengler, MD||South Texas Oncology and Hematology - Wurzbach Road|