NCT00005874

Nitrocamptothecin in Treating Patients With Soft Tissue Sarcomas

Phase II Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) in Patients With Soft-Tissue Sarcomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Astex Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: —
• 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 nitrocamptothecin in treating patients who have locally advanced or metastatic soft tissue sarcomas.

Detailed description

OBJECTIVES: I. Assess the efficacy and toxicity of nitrocamptothecin in patients with locally advanced or metastatic gastrointestinal leiomyosarcomas or other soft tissue sarcomas. OUTLINE: Patients are stratified by disease (gastrointestinal leiomyosarcomas vs other soft tissue sarcomas). Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly in the absence of disease progression or unacceptable toxicity. Responding patients who undergo surgery then receive an additional 4-6 courses (4 weeks/course). PROJECTED ACCRUAL: A total of 34-78 patients (17-39 per stratum) will be accrued for this study.

Conditions

• Gastrointestinal Stromal Tumor
• Sarcoma
• Small Intestine Cancer

Interventions

Type	Name	Description
DRUG	rubitecan

Timeline

• Start date: 1999-06-01
• Completion: 2004-04-01
• First posted: 2004-04-13
• Last updated: 2013-12-04

Locations

1 site across 1 country: United States