Trials / Completed
CompletedNCT00003939
Ecteinascidin 743 in Treating Patients With Advanced Soft Tissue Sarcoma
Phase II Study on ET-743 in Advanced Soft Tissue Sarcomas of the Adult
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 132 (actual)
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Brain and Central Nervous System Tumors
- Endometrial Cancer
- Gastrointestinal Stromal Tumor
- Ovarian Cancer
- Sarcoma
- Small Intestine Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | trabectedin |
Timeline
- Primary completion
- 2000-11-01
- First posted
- 2004-06-03
- Last updated
- 2012-09-24
Source: ClinicalTrials.gov record NCT00003939. Inclusion in this directory is not an endorsement.