Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00474994
Status:
COMPLETED
Last Update Posted:
2016-01-20
First Post:
2007-05-16
Brief Title:
Sunitinib in Treating Patients With Metastatic Locally Advanced or Locally Recurrent Sarcomas
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Multicenter Phase II Study of Continuous Dosing of Sunitinib Sutent SU11248 in Non-GIST Sarcomas
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA008748 | NIH | None | None |
| MSKCC-07054 | None | None | None |
| PFIZER-MSKCC-07054 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |