Expired Study
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Burlingame, California 94010


Purpose:

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 well sorafenib works in treating patients with advanced soft tissue sarcomas.


Study summary:

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 survival rate in patients treated with this drug. - Determine the frequency and severity of adverse events in patients treated with this drug. OTHER OBJECTIVES (if funding permits): - Correlate, preliminarily, a decrease in standard uptake variable (SUV) of target lesions by positron-emission tomography scan at 4 weeks with response in patients treated with this drug. - Correlate, preliminarily, the phosphorylation status of KIT, PDGFR, VEGFR, and the raf/mek/erk pathway with response in patients treated with this drug. - Correlate, preliminarily, the most common B-raf kinase mutation with response in patients treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to histology (leiomyosarcoma vs liposarcoma vs angiosarcoma, hemangiosarcoma, or hemangiopericytoma). Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 8 weeks until disease progression and then every 6 months for 2 years and annually for up to 3 years. PROJECTED ACCRUAL: A total of 45-75 patients (15-25 per stratum) will be accrued for this study within 15-38 months.


Criteria:

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


NCT ID:

NCT00217620


Primary Contact:

Study Chair
Margaret von Mehren, MD
Fox Chase Cancer Center


Backup Contact:

N/A


Location Contact:

Burlingame, California 94010
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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