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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 combining flavopiridol, irinotecan, and cisplatin in treating patients who have advanced solid tumors.
- Determine the maximum tolerated dose of flavopiridol, irinotecan, and cisplatin in patients with advanced solid tumors.
- Determine the clinical pharmacokinetics of this regimen in these patients.
- Determine, preliminarily, the therapeutic activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study. Patients are stratified according to the number of prior treatment regimens (0 or 1 vs more than 1).
Patients receive irinotecan IV over 30 minutes followed immediately by cisplatin IV over 30 minutes followed 7 hours later by flavopiridol IV over 1-4.5 hours weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of cisplatin, flavopiridol, and irinotecan until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 12 additional patients are treated at the recommended phase II dose.
PROJECTED ACCRUAL: A minimum of 13 patients will be accrued for this study.
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
alvocidib, cisplatin, irinotecan hydrochloride
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:55:46-0400
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