A Study of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Soft Tissue Sarcomas

Date de début de l'étude : 1 juillet 2004

Inclusion Criteria: * Must be 18 years of age or older with histologic diagnosis of soft tissue sarcoma * Must have disease not suitable for curative resection * Must have failed \>1 first line treatment with evidence of progression. Adjuvant therapy does not count as 1st line therapy unless recurrence occurs within 6 months of administration * Must have ability to understand and the willingness to sign a written informed consent document * Must have Eastern Cooperative Oncology Group (ECOG) performance status of \< 2 * Must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria * At least 4 weeks have passed since the last chemotherapy, immunotherapy, or radiation therapy * There must be measurable disease outside the radiotherapy fields or progression of the indicator lesions within the field since the completion of the radiotherapy * Must have a life expectancy of greater than 12 weeks * Must have clinical laboratory values at screening as defined below: * Hemoglobin \>9 g/dL, * Absolute neutrophil count \>1500/mm3, * Platelet count \>100,000/mm3, * Creatinine \<1.5 X ULN, * Bilirubin \<1.5 X ULN, * Asparate aminotransferase and alanine aminotransferase \<2.5 X ULN (\<5 X ULN in presence of liver metastases) Exclusion Criteria: * Female patients who are pregnant or breast feeding * Patients of childbearing potential not using or not willing to use a barrier method of contraception * Prior malignancy other than soft tissue sarcoma (STS) within the last 5 yrs with the exception of: * Adequately treated in situ carcinoma of the cervix uteri; * Basal or squamous cell carcinoma of the skin * Presence of a clinically significant and uncontrolled infection * Presence of \>Grade 2 neuropathy * Symptomatic central nervous system metastases within last 8 weeks or on corticosteroids for CNS symptom management * Presence of clinically significant arrythmias * Presence of a serious concurrent illness or other conditions (e.g., psychological, family, sociological, or geographical circumstances) that do not permit adequate follow-up and compliance with the protocol * History of severe hypersensitivity reactions to taxanes or cremaphore in spite of premedication * Use of any investigational agents within 4 weeks prior to the first dose of study drug(s) * Major surgery within 2 weeks of screening * Radiation treatment in past \>25% of bone marrow