Sunitinib in Treating Patients With Metastatic, Locally Advanced, or Locally Recurrent Sarcomas
Condition: Adult Malignant Fibrous Histiocytoma of Bone; Desmoid Tumor; Endometrial Cancer; Ovarian Cancer; Sarcoma; Small Intestine Cancer
MeSH terms: Sarcoma; Endometrial Neoplasms; Fibromatosis, Aggressive; Intestinal Neoplasms; Histiocytoma; Histiocytoma, Benign Fibrous; Histiocytoma, Malignant Fibrous
Study type: Interventional
Phase: Phase 2

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 description: 
      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.
    

Intervention name(s): sunitinib malate
Intervention type(s): Drug
Intervention MeSH terms: Sunitinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chondrosarcoma; recurrent osteosarcoma; localized adult malignant fibrous histiocytoma of bone; metastatic adult malignant fibrous histiocytoma of bone; recurrent adult malignant fibrous histiocytoma of bone; recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor; recurrent Kaposi sarcoma; recurrent uterine sarcoma; adult leiomyosarcoma; adult malignant fibrous histiocytoma; adult rhabdomyosarcoma; dermatofibrosarcoma protuberans; stage III adult soft tissue sarcoma; stage IV adult soft tissue sarcoma; ovarian sarcoma; uterine leiomyosarcoma; stage III uterine sarcoma; stage IV uterine sarcoma; desmoid tumor; adult angiosarcoma; recurrent adult soft tissue sarcoma; uterine carcinosarcoma; endometrial stromal sarcoma; fibrosarcomatous osteosarcoma; chondrosarcomatous osteosarcoma; adult alveolar soft-part sarcoma; adult epithelioid sarcoma; adult extraskeletal chondrosarcoma; adult extraskeletal osteosarcoma; adult fibrosarcoma; adult malignant hemangiopericytoma; adult malignant mesenchymoma; adult neurofibrosarcoma; adult synovial sarcoma; adult desmoplastic small round cell tumor; adult liposarcoma; anaplastic osteosarcoma; mixed osteosarcoma; small intestine leiomyosarcoma; osteoblastic osteosarcoma; telangiectatic osteosarcoma; classic Kaposi sarcoma; immunosuppressive treatment related Kaposi sarcoma; AIDS-related Kaposi sarcoma