Spots Global Cancer Trial Database for Gemcitabine Plus Flavopiridol in Treating Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: Gemcitabine Plus Flavopiridol in Treating Patients With Advanced Solid Tumors

Official Title: A Phase I Trial Of Gemcitabine Followed By Flavopiridol In Patients With Solid Tumors

Study ID: NCT00007917

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

alvocidib

gemcitabine hydrochloride

Study Description

Brief Summary: Phase I trial to study the effectiveness of gemcitabine plus flavopiridol in treating patients who have advanced solid tumors. 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.

Detailed Description: OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine and flavopiridol in patients with advanced solid tumors. II. Determine the toxicity and safety profile of this regimen in these patients. III. Determine the pharmacokinetic profile of this regimen in this patient population. OUTLINE: This is a dose-escalation study. Patients receive gemcitabine IV over 1-2.5 hours on days 1 and 8 and flavopiridol IV continuously over 24 hours on days 2 and 9. Courses repeat every 21 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 reached. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 6-58 patients will be accrued for this study.