RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have advanced soft tissue sarcoma.

Condition	Treatment or Intervention	Phase
stage IVB adult soft tissue sarcoma recurrent adult soft tissue sarcoma stage IVA adult soft tissue sarcoma stage III adult soft tissue sarcoma	Drug: BMS-247550	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically confirmed soft tissue sarcoma; Metastatic or unresectable disease
• Measurable disease; At least 1 lesion measurable in at least 1 dimension; At least 2.0 cm by conventional techniques; No truly nonmeasurable lesions, including the following: Bone lesions; Leptomeningeal disease; Ascites Pleural/pericardial effusion; Inflammatory breast disease; Lymphangitis cutis/pulmonis; Abdominal masses not confirmed and followed by imaging techniques; Cystic lesions
• No uncontrolled brain metastases; Previously treated brain metastasis that is controlled for more than 8 weeks allowed

--Prior/Concurrent Therapy--

• Biologic therapy: No concurrent anticancer immunomodulating agents; No concurrent prophylactic colony-stimulating factors for granulocytopenia
• Chemotherapy: At least 4 weeks since prior neoadjuvant or adjuvant chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered; No prior chemotherapy for metastatic disease; No other concurrent cytostatic or cytotoxic anticancer chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: At least 4 weeks since prior radiotherapy and recovered; No prior radiotherapy to only site of measurable disease unless documented increase of more than 25% in lesion size since completion of radiotherapy; No concurrent anticancer radiotherapy
• Surgery: See Disease Characteristics
• Other: No other concurrent anticancer investigational therapy or commercial agents; No concurrent unconventional therapies or food supplements; No concurrent combination antiretroviral therapy for HIV-positive patients

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2
• Life expectancy: More than 12 weeks
• Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); AST no greater than 2.5 times ULN
• Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min
• Cardiovascular: No symptomatic congestive heart failure; No unstable angina pectoris; No cardiac arrhythmia
• Other: No prior allergic reactions to compounds of similar chemical or biological composition to BMS-247550 or polyoxyethelated castor oil (Cremaphor EL); No grade 2 or greater motor or sensory neuropathy; No other uncontrolled illness; No ongoing or active infection; No psychiatric illness or social situation that would preclude study; No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, noninvasive carcinomas, or localized prostate cancer; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception

Arizona
      Mayo Clinic Scottsdale, Scottsdale,  Arizona,  85259,  United States
District of Columbia
      Howard University College of Medicine, Washington,  District of Columbia,  20059,  United States
Florida
      Mayo Clinic Jacksonville, Jacksonville,  Florida,  32224,  United States
Maryland
      Johns Hopkins Oncology Center, Baltimore,  Maryland,  21231-2410,  United States
Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201-1379,  United States
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Missouri
      Washington University School of Medicine, Saint Louis,  Missouri,  63110,  United States
Wisconsin
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-6164,  United States

Study chairs or principal investigators

Scott Okuno,  Study Chair,  Mayo Clinic Cancer Center   

Study ID Numbers:  CDR0000068829; MAYO-MC007C; NCI-3852
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  August 10, 2001
ClinicalTrials.gov Identifier:  NCT00022542
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08