A Multicenter Phase II Study of Continuous Dosing of Sunitinib (Sutent®, SU11248) in Non-GIST 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (complete response [CR] and partial response [PR]) as assessed by RECIST criteria
2 years
No
Mary L. Keohan, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
07-054
NCT00474994
April 2007
November 2010
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |