Nitrocamptothecin in Treating Patients With Soft Tissue Sarcomas

Phase 2

Completed

• Conditions: Sarcoma; Small Intestine Cancer; Gastrointestinal Stromal Tumor

• Registration Number: NCT00005874
• Lead Sponsor: Astex Pharmaceuticals, Inc.

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 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.

Study Timeline

• Study Start: 1999-06
• Study First Submitted: 2000-06-02
• Status Verified: 2001-09
• Study Completion: 2004-04
• Study First Submitted QC: 2004-04-12
• Study First Posted: 2004-04-13
• Last Update Submitted: 2013-12-03
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

SuperGen, Incorporated; 🇺🇸 Dublin, California, United States