SU5416 in Treating Patients With Advanced, Metastatic, or Recurrent Soft Tissue Sarcomas
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00005862|
Recruitment Status : Completed
First Posted : February 12, 2004
Last Update Posted : February 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Stromal Tumor Sarcoma||Drug: semaxanib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005862
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Study Chair:||George D. Demetri, MD||Dana-Farber Cancer Institute|