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

Completed · Phase 2

Conditions studied: Soft Tissue Sarcoma

In brief

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.

Key facts

Study ID

NCT00087997

Run by

Synta Pharmaceuticals Corp.

People needed

80

Starts

2004-07-01

Expected to finish

2005-10-01

Last updated by the study team

2006-06-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Arizona Cancer Center — Scottsdale, Arizona, United States
• Arizona Cancer Center — Tucson, Arizona, United States
• UCLA — Los Angeles, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Palm Beach Cancer Institute — West Palm Beach, Florida, United States
• Winship Cancer Institute — Atlanta, Georgia, United States
• University of Chicago Department of Medicine — Chicago, Illinois, United States
• Via Christi Regional Med. Center (Wichita CCOP) — Wichita, Kansas, United States
• University of Louisville Hospital — Louisville, Kentucky, United States
• Feist-Weiller Cancer Center — Shreveport, Louisiana, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Wayne State University — Detroit, Michigan, United States
• Genesys Hurley Cancer Institute — Flint, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• NYU Cancer Institute Clinical Center — New York, New York, United States
• Herbert Irving Cancer Center — New York, New York, United States
• Carolinas Medical Center/Blumenthal Cancer Center — Charlotte, North Carolina, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• The West Clinic — Memphis, Tennessee, United States
• The Sarah Cannon Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.