NCT00005875

Nitrocamptothecin in Treating Patients With Metastatic Melanoma

Phase II Evaluation of RFS 2000 (9-Nitro-Camptothecin, 9NC) in Metastatic Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Astex Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 16 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 nitrocamptothecin in treating patients who have metastatic melanoma.

Detailed description

OBJECTIVES: I. Assess the efficacy and toxicity of nitrocamptothecin in patients with metastatic melanoma. OUTLINE: Patients are stratified according to disease (choroidal vs nonchoroidal). Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly for at least 8 weeks (2 courses) in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 28-74 patients (14-37 per stratum) will be accrued for this study.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
DRUG	rubitecan

Timeline

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

Locations

1 site across 1 country: United States