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 ]

as assessed by RECIST criteria


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