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RATIONALE: Drugs used in chemotherapy, such as gemcitabine and flavopiridol, 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: This phase I trial is studying the side effects and best dose of gemcitabine and flavopiridol in treating patients with solid tumors.
- Determine the maximum tolerated dose of gemcitabine and flavopiridol in patients with solid tumors.
- Determine the safety profile and toxic effects of this regimen in these patients.
- Determine the pharmacokinetics of flavopiridol with and without gemcitabine in these patients.
- Determine, using pharmacodynamic assays, the activity of flavopiridol as a cdk inhibitor in these patients.
- Determine, using pharmacodynamic assays, the markers of this regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Some patients receive an initial dose of flavopiridol IV over 1-7 hours on day 1 (course 0). Beginning 1 week later and for all subsequent courses, all patients receive gemcitabine IV over 60-150 minutes on days 1 and 15 and flavopiridol IV over 1-7 hours on days 2 and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gemcitabine and flavopiridol 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 toxicity. Once the MTD is determined, up to 10 additional patients receive treatment at that dose.
Patients are followed at 30 days after study completion.
PROJECTED ACCRUAL: A total of 40-80 patients will be accrued for this study.
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
alvocidib, gemcitabine hydrochloride
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:54:47-0400
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