Spots Global Cancer Trial Database for Gemcitabine Hydrochloride and Alvocidib in Treating Patients With Solid Tumors

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Gemcitabine Hydrochloride and Alvocidib in Treating Patients With Solid Tumors

Official Title: A Phase I Trial of Gemcitabine Followed by a Short Infusion of Flavopiridol in Patients With Solid Tumors

Study ID: NCT00072436

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

gemcitabine hydrochloride

alvocidib

pharmacological study

Study Description

Brief Summary: This phase I trial is studying the side effects and best dose of gemcitabine hydrochloride and alvocidib in treating patients with solid tumors. Drugs used in chemotherapy, such as gemcitabine hydrochloride and alvocidib, 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: PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine and flavopiridol in patients with solid tumors. SECONDARY OBJECTIVES: I. Determine the safety profile and toxic effects of this regimen in these patients. II. Determine the pharmacokinetics of flavopiridol with and without gemcitabine in these patients. III. Determine, using pharmacodynamic assays, the activity of flavopiridol as a cdk inhibitor in these patients. IV. 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 alvocidib IV over 1-7 hours on day 1 (course 0). Beginning 1 week later and for all subsequent courses, all patients receive gemcitabine hydrochloride IV over 60-150 minutes on days 1 and 15 and alvocidib 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 hydrochloride and alvocidib 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.