BMS-247550 in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have advanced solid tumors that have not responded to previous therapy.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: ixabepilone||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study of BMS-247550 Given Every Three Weeks in Patients With Advanced Malignancies|
|Study Start Date:||July 1999|
|Study Completion Date:||October 2002|
|Primary Completion Date:||October 2002 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the maximum tolerated dose, dose limiting toxicities, safety, and a recommended phase II dose of BMS-247550 administered as a 1 hour infusion every 3 weeks in patients with advanced solid tumors. II. Evaluate the plasma pharmacokinetics of this drug in this patient population. III. Determine any preliminary evidence of antitumor activity of this drug in these patients.
OUTLINE: This is a dose escalation study. Patients receive BMS-247550 IV over 1 hour every 3 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. 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 2 of 3 or 2 of 6 patients experience dose limiting toxicities. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study within 8-12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004927
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||David R. Spriggs, MD||Memorial Sloan Kettering Cancer Center|