Combination Chemotherapy 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 combining flavopiridol with docetaxel in treating patients who have advanced solid tumors.
Unspecified Adult Solid Tumor, Protocol Specific
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Single Center Open-Label Non-Comparative Phase I Dose Finding Study Of Weekly Flavopiridol In Combination With Weekly Docetaxel In Patients With Advanced Solid Tumors|
|Study Start Date:||April 2002|
|Study Completion Date:||December 2009|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose of flavopiridol when administered in combination with 2 different doses of docetaxel 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 of flavopiridol.
Patients receive docetaxel IV over 30 minutes followed at least 4 hours later by flavopiridol IV over 1 hour on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Separate MTDs of flavopiridol are determined when flavopiridol is combined with 2 different doses of docetaxel. A total of 10 patients are treated at each flavopiridol MTD.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 6-56 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045448
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Gary K. Schwartz, MD||Memorial Sloan Kettering Cancer Center|