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

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and effectiveness of an experimental study drug (STA-4783) combined with an approved cancer medicine, paclitaxel, in the treatment of soft tissue sarcomas. Paclitaxel (Taxol®) has been approved and used in the United States since 1992.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Synta Pharmaceuticals Corp.

Criteria

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