BMS-247550 in Treating Patients With Advanced Soft Tissue Sarcoma

Exclusion Criteria

• •Any of the following as the effects of Epothilone B analog, BMS-247550, on the developing fetus or nursing child, at the recommended therapeutic dose are unknown:
• •* Pregnant women
• •* Nursing women
• •* Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, or abstinence, etc.)
• •Only non-measurable disease, including lesions not clearly measurable in one dimension, small lesions (longest diameter \< 2.0 cm), and truly non-measurable lesions, which include the following as per RECIST criteria:
• •* Bone lesions
• •* Leptomeningeal disease
• •* Ascites
• •* Pleural/pericaridial effusion
• •* Inflammatory breast disease
• •* Lymphangitis cutis/pulmonis
• •* Abdominal masses that are not confirmed and followed by imaging techniques
• •* Cystic lesions
• •Only a single measurable lesion and that lesion has been irradiated unless there has been a documented \> 25% increase in size since completion of radiation
• •Any of the following:
• •* Prior chemotherapy for metastatic soft tissue sarcoma (neoadjuvant or adjuvant chemotherapy allowed)
• •* Prior nitrosoureas or mitomycin C less than or equal to 6 weeks prior to study entry
• •* Prior other neoadjuvant or adjuvant chemotherapy less than or equal to 4 weeks prior to study entry
• •* Prior radiotherapy less than or equal to 4 weeks prior to study entry
• •* Failure to recover from adverse effects of prior therapy regardless of time frame since receiving the therapy
• •* Concurrent other investigational therapy, unconventional therapies, or food supplements
• •Uncontrolled brain metastases; (Note: these patients are excluded because of the poor prognosis and because the propensity for progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events); however, if brain metastases are treated and controlled for \> 8 weeks, they would be eligible for this study
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to Epothilone B analog, BMS-247550 or polyoxyethylated castor oil (Cremophor\[R\] EL)
• •Motor or sensory neuropathy \>= grade 2 (per NCI CTC version 2.0)
• •Known HIV-positive patients receiving combination anti-retroviral therapy; Note: patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy and because of possible pharmacokinetic interactions with Epothilone B analog, BMS-247550; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• •Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas, treated localized prostate cancer, or other cancer from which the patient has been disease-free for at least 5 years