Clinical Trial: Sunitinib in Treating Patients With Metastatic, Locally Advanced, or Locally Recurrent Sarcomas
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter Phase II Study of Continuous Dosing of Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
Brief Summary:
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.
Detailed Summary:
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.
Sponsor: Memorial Sloan Kettering Cancer Center
Current Primary Outcome: Overall Objective Response [ Time Frame: 2 years ]
Original Primary Outcome: Response rate (complete response [CR] and partial response [PR]) as assessed by RECIST
Current Secondary Outcome:
Original Secondary Outcome:
- Progression-free survival rate (CR, PR, and stable disease) as assessed at 16 and 24 weeks
- Overall survival
- Correlation of clinical response with changes in soluble angiogenesis mediator levels as assessed at baseline and at 2 weeks (for patients enrolled at the Memorial Sloan-Kettering Cancer Center)
- Tumor maximum standardized uptake value as assessed by fludeoxyglucose F 18-PET scan at baseline and at 2 weeks and correlation with clinical response
Information By: Memorial Sloan Kettering Cancer Center
Dates:
Date Received: May 16, 2007
Date Started: April 2007
Date Completion:
Last Updated: December 15, 2015
Last Verified: December 2015