Trials / Terminated
TerminatedNCT00022542
BMS-247550 in Treating Patients With Advanced Soft Tissue Sarcoma
A Phase II Study of Epothilone B Analog (BMS-247550) in Advanced Soft Tissue Sarcomas
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Recurrent Adult Soft Tissue Sarcoma
- Stage III Adult Soft Tissue Sarcoma
- Stage IV Adult Soft Tissue Sarcoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ixabepilone | Given IV |
Timeline
- Start date
- 2001-06-01
- Primary completion
- 2006-06-01
- Completion
- 2006-06-01
- First posted
- 2004-02-27
- Last updated
- 2015-04-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00022542. Inclusion in this directory is not an endorsement.