A Study of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Soft Tissue Sarcomas
1 other identifier
interventional
80
2 countries
27
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2004
Shorter than P25 for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 19, 2004
CompletedFirst Posted
Study publicly available on registry
July 23, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedJune 20, 2006
June 1, 2006
July 19, 2004
June 19, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
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,
- +1 more criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Arizona Cancer Center
Scottsdale, Arizona, 85258, United States
Arizona Cancer Center
Tucson, Arizona, 85724, United States
UCLA
Los Angeles, California, 90095, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
University of Florida
Gainesville, Florida, 32610, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401, United States
Winship Cancer Institute
Atlanta, Georgia, 30322, United States
University of Chicago Department of Medicine
Chicago, Illinois, 60637, United States
Via Christi Regional Med. Center (Wichita CCOP)
Wichita, Kansas, 67214, United States
University of Louisville Hospital
Louisville, Kentucky, 40202, United States
Feist-Weiller Cancer Center
Shreveport, Louisiana, 71103, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Wayne State University
Detroit, Michigan, 48201, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
NYU Cancer Institute Clinical Center
New York, New York, 10016, United States
Herbert Irving Cancer Center
New York, New York, 10032, United States
Carolinas Medical Center/Blumenthal Cancer Center
Charlotte, North Carolina, 28203, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
The West Clinic
Memphis, Tennessee, 38120, United States
The Sarah Cannon Cancer Center
Nashville, Tennessee, 37203, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 19, 2004
First Posted
July 23, 2004
Study Start
July 1, 2004
Study Completion
October 1, 2005
Last Updated
June 20, 2006
Record last verified: 2006-06