NCT00003719

Irinotecan in Treating Patients With Stage IV or Recurrent Soft Tissue Sarcoma

Phase II Evaluation of Irinotecan (CPT-11) in Previously Treated Advanced Sarcomas

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Herbert Irving Comprehensive Cancer Center · Academic / Other
• 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 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.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	irinotecan hydrochloride

Timeline

• Start date: 1997-07-01
• First posted: 2004-04-14
• Last updated: 2014-01-06

Locations

1 site across 1 country: United States