Phase II trial to study the effectiveness of BMS-247550 in treating patients who have advanced soft tissue sarcoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
OBJECTIVES: I. Determine the confirmed response rate of patients with advanced soft tissue sarcoma treated with BMS-247550. II. Determine the overall survival and progression-free survival of patients treated with this drug. III. Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive BMS-247550 IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response receive 2 additional courses. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 14-29 patients will be accrued for this study within 8 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Given IV
Mayo Clinic
Rochester, Minnesota, United States
Confirmed tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST)
Ninety-five percent confidence intervals will be calculated according to the approach of Duffy and Santner.
Time frame: Up to 5 years
Overall survival
Estimated using the method of Kaplan-Meier.
Time frame: Time from registration to death due to any cause, assessed up to 5 years
Time to disease progression
Estimated using the method of Kaplan-Meier.
Time frame: Time from registration to documentation of disease progression, assessed up to 5 years
Quality and duration of responses
Time frame: Date at which the patient's objective status is first noted to be either a complete response (CR) or partial response (PR) to the date progression is documented, assessed up to 5 years
Time to treatment failure
Time frame: Date of registration to date of progression, toxicity, or removal, assessed up to 5 years
Toxicities graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
Time frame: Up to 5 years
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