SU5416 in Treating Patients With Advanced, Metastatic, or Recurrent Soft Tissue Sarcomas
Phase II trial to study the effectiveness of SU5416 in treating patients who have advanced, metastatic, or recurrent soft tissue sarcomas. SU5416 may stop the growth of soft tissue sarcomas by stopping blood flow to the tumor.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of SU5416 (NSC #696819) in Previously Treated Patients With Advanced, Metastatic and/or Locally Recurrent Soft Tissue Sarcomas|
|Study Start Date:||October 2000|
|Primary Completion Date:||July 2004 (Final data collection date for primary outcome measure)|
Experimental: Arm I
atients receive SU5416 IV twice weekly for 4 weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
I. Determine the response rate, response duration, and overall survival in patients with advanced, metastatic, or recurrent soft tissue sarcoma or gastrointestinal stromal tumor when treated with SU5416.
II. Determine the safety of SU5416 in these patients.
OUTLINE: This is a multicenter study.
Patients receive SU5416 IV twice weekly for 4 weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 3 months and then every 3 months for 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005862
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Study Chair:||George D. Demetri, MD||Dana-Farber Cancer Institute|