Status:
COMPLETED
S0505 Sorafenib in Treating Patients With Advanced Soft Tissue Sarcomas
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how we...
Detailed Description
OBJECTIVES: * Determine the objective response rate (confirmed, complete, and partial) in patients with advanced soft tissue sarcomas treated with sorafenib. * Determine the 4-month progression-free ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed soft tissue sarcoma of 1 of the following histologies:
- Angiosarcoma, cutaneous or visceral
- Malignant hemangiosarcoma
- Malignant hemangiopericytoma
- Grade 3-4 leiomyosarcoma
- Grade 3-4 liposarcoma
- Must have evidence of unresectable residual disease, metastatic disease, or recurrent disease by radiography
- Measurable disease by x-ray, scans, or physical examination
- Archived paraffin-embedded tumor sections available
- No known brain metastases
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Zubrod 0-1
- Life expectancy
- Not specified
- Hematopoietic
- WBC ≥ 3,000/mm\^3
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver metastases)
- Bilirubin normal (≤ 2.5 times ULN if due to liver metastases)
- PT, PTT, and INR normal
- Renal
- Creatinine normal OR
- Creatinine clearance ≥ 60 mL/min
- Cardiovascular
- No history of thromboembolic disease
- No uncontrolled hypertension
- Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Able to swallow oral medication
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- At least 28 days since prior chemotherapy (42 days for carmustine or mitomycin) and recovered
- Prior adjuvant chemotherapy allowed
- No more than 1 prior chemotherapy regimen for metastatic disease
- Endocrine therapy
- Not specified
- Radiotherapy
- At least 28 days since prior radiotherapy and recovered
- Must have evidence of disease progression within, or measurable disease outside of, the radiation field after completion of radiotherapy
- Surgery
- At least 28 days since prior major surgery and recovered
- Other
- No prior sorafenib
- No prior inhibitor of VEGFR or MAPK pathway
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational agents
- No concurrent therapeutic anticoagulation
- No concurrent administration of any of the following medications:
- Rifampin
- Hypericum perforatum (St. John's wort)
- Cytochrome P450 enzyme-inducing antiepileptic drugs, including any of the following:
- Phenytoin
- Carbamazepine
- Phenobarbital
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00217620
Start Date
March 1 2006
End Date
September 1 2012
Last Update
May 15 2014
Active Locations (184)
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1
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
2
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94704
4
Peninsula Medical Center
Burlingame, California, United States, 94010