Ovarian Cancer Clinical Trial
Official title:
A Multicenter Phase II Study of Continuous Dosing of Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
RATIONALE: Sunitinib 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 sunitinib works in treating patients with
metastatic, locally advanced, or locally recurrent sarcomas.
OBJECTIVES:
Primary
- Determine the response rate (complete response and partial response) in patients with
metastatic, locally advanced, or locally recurrent non-gastrointestinal stromal tumor
sarcomas treated with sunitinib malate.
Secondary
- Determine the 16- and 24-week progression-free survival rate (complete response,
partial response, and stable disease) in patients treated with this drug.
- Determine the overall survival in patients treated with this drug.
- Correlate clinical response with changes in soluble angiogenesis mediator levels in
patients treated with this drug.
- Determine the tumor maximum standardized uptake values by fludeoxyglucose F 18-PET scan
in patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified by neoplastic subtype
(vascular connective tissue neoplasms, leiomyosarcoma, dermatofibrosarcoma protuberans,
chordoma, or desmoid tumors vs high-grade undifferentiated pleomorphic sarcoma [i.e.,
malignant fibrous histiocytoma (including myxofibrosarcoma)], or other nongastrointestinal
connective tissue tumors [including carcinosarcomas]).
Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 4 weeks
in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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