Sorafenib and Dacarbazine in Soft Tissue Sarcoma
|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: NCT00837148|
Recruitment Status : Completed
First Posted : February 5, 2009
Results First Posted : November 20, 2015
Last Update Posted : November 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma Synovial Sarcoma Leiomyosarcoma Malignant Peripheral Nerve Sheath Tumor||Drug: Sorafenib and Dacarbazine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Sorafenib and Dacarbazine in Soft Tissue Sarcoma|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Experimental: Sorafenib and Dacarbazine
This study is an open label, single arm, Simon two stage, phase 2 trial of continuous, daily oral sorafenib, with intravenous dacarbazine administered every three weeks for patients with synovial sarcoma, leiomyosarcoma and malignant peripheral nerve sheath tumor.
Drug: Sorafenib and Dacarbazine
Treatment will be administered on an outpatient basis. Sorafenib is supplied as 200-mg tablets. The starting dose of sorafenib will be 400 mg PO twice daily (every 12 hours) continuously. There is no planned treatment interruption between cycles.
All patients will receive dacarbazine as an open-label dose of 850 mg/m2 by IV infusion over 60 minutes, starting on Week 1 and repeated every 3 weeks until disease progression or intolerance.
- Overall Objective Response [ Time Frame: at 18 weeks ]Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
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): NCT00837148
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||William Tap, MD||Memorial Sloan Kettering Cancer Center|