Trials / Completed
CompletedNCT00474994
Sunitinib in Treating Patients With Metastatic, Locally Advanced, or Locally Recurrent Sarcomas
A Multicenter Phase II Study of Continuous Dosing of Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 53 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Adult Malignant Fibrous Histiocytoma of Bone
- Desmoid Tumor
- Endometrial Cancer
- Ovarian Cancer
- Sarcoma
- Small Intestine Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sunitinib malate |
Timeline
- Start date
- 2007-04-01
- Primary completion
- 2010-11-01
- Completion
- 2010-11-01
- First posted
- 2007-05-17
- Last updated
- 2016-01-20
- Results posted
- 2016-01-20
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00474994. Inclusion in this directory is not an endorsement.