BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors
|ClinicalTrials.gov Identifier: NCT00043095|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 24, 2008
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 BMS-247550 with gemcitabine in treating patients who have advanced solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: gemcitabine hydrochloride Drug: ixabepilone||Phase 1|
- Determine the maximum tolerated dose, dose-limiting toxicity, and safety of BMS-247550 when combined with gemcitabine in patients with advanced solid tumors.
- Determine the plasma pharmacokinetics of this regimen in this patient population.
- Assess, preliminarily, any antitumor activity of this regimen in this patient population.
OUTLINE: This is a dose-escalation study of BMS-247550.
Patients receive gemcitabine IV over 90 minutes on days 1 and 8 followed by BMS-247550 IV over 3 hours on day 8. The order of chemotherapy drug administration on day 8 is reversed during the second course only. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BMS-247550 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. Once the MTD is determined, 9 patients total are treated at the MTD.
PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase I Trial of BMS 247550 (NSC# 710428) and Gemcitabine in Patients With Advanced Solid Tumor Malignancies|
|Study Start Date :||June 2002|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00043095
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Sibyl Anderson, MD||Memorial Sloan Kettering Cancer Center|