Phase II Evaluation of Irinotecan (CPT-11) in Previously Treated Advanced Sarcomas
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Sarcoma
- Sponsor
- Herbert Irving Comprehensive Cancer Center
- Enrollment
- 27
- Locations
- 1
- Last Updated
- 12 years ago
Overview
Brief 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 irinotecan in treating patients who have stage IV or recurrent soft tissue sarcoma that has been previously treated with chemotherapy.
Detailed Description
OBJECTIVES: I. Evaluate the efficacy of irinotecan in patients with metastatic, recurrent, or unresectable locally advanced previously treated soft tissue sarcoma. II. Assess the clinical and laboratory toxic effects and patient tolerance of this regimen in these patients. OUTLINE: Patients receive irinotecan IV over 90 minutes weekly for 4 weeks, followed by 2 weeks of rest. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for the first two years, then every 6 months for the next two years, and every 12 months thereafter until death. PROJECTED ACCRUAL: A total of 14-27 patients will be accrued for this study in 18-36 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified