Status:
COMPLETED
A Study of STA-4783 in Combination With Weekly Paclitaxel for Treatment of Patients With Soft Tissue Sarcomas
Lead Sponsor:
Synta Pharmaceuticals Corp.
Conditions:
Soft Tissue Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 sa...
Detailed Description
STA-4783 is a taxane potentiator, enhancing the effect of antitumor response of paclitaxel. In an attempt to improve efficacy, paclitaxel is sometimes used in combination with other anticancer agents....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00087997
Start Date
July 1 2004
End Date
October 1 2005
Last Update
June 20 2006
Active Locations (27)
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1
Arizona Cancer Center
Scottsdale, Arizona, United States, 85258
2
Arizona Cancer Center
Tucson, Arizona, United States, 85724
3
UCLA
Los Angeles, California, United States, 90095
4
Yale University School of Medicine
New Haven, Connecticut, United States, 06520