Ecteinascidin 743 in Treating Patients With Advanced 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: NCT00003939|
Recruitment Status : Completed
First Posted : June 3, 2004
Last Update Posted : September 24, 2012
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients who have advanced soft tissue sarcoma.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Endometrial Cancer Gastrointestinal Stromal Tumor Ovarian Cancer Sarcoma Small Intestine Cancer||Drug: trabectedin||Phase 2|
OBJECTIVES: I. Determine the therapeutic activity of ecteinascidin 743 in patients with advanced soft tissue sarcomas. II. Determine the duration of response in these patients. III. Determine the acute side effects in these patients.
OUTLINE: This is a multicenter study. Patients receive ecteinascidin 743 (ET-743) IV over 24 hours every 3 weeks. Treatment continues for at least 2-6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression and every 12 weeks after disease progression.
PROJECTED ACCRUAL: Approximately 28-44 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||132 participants|
|Official Title:||Phase II Study on ET-743 in Advanced Soft Tissue Sarcomas of the Adult|
|Actual Primary Completion Date :||November 2000|
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): NCT00003939
|Study Chair:||Axel Le Cesne, MD||Gustave Roussy, Cancer Campus, Grand Paris|