A Study of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Soft Tissue Sarcomas
NCT ID: NCT00087997
Last Updated: 2006-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2004-07-31
2005-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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STA-4783
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Synta Pharmaceuticals Corp.
INDUSTRY
Locations
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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
MD Anderson Cancer Center
Houston, Texas, United States
Mount Sinai Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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4783-04
Identifier Type: -
Identifier Source: org_study_id