Sarcoma Clinical Trial
Official title:
Phase II Trial of BAY-9006 (NSC #724772) in Advanced Soft Tissue Sarcomas
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.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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