NCT00006026

Nitrocamptothecin in Treating Patients With Metastatic Cancer of the Urinary Tract

Open Label Phase II Study on RFS 2000 (9-Nitro-Camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Advanced/Metastatic Urothelial Tract Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• 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 nitrocamptothecin in treating patients who have metastatic cancer of the urinary tract.

Detailed description

OBJECTIVES: I. Determine the objective response to nitrocamptothecin in patients with metastatic urothelial tract tumors. II. Determine the response rate in these patients when treated with this regimen. III. Determine the duration of objective response in these patients when treated with this regimen. IV. Characterize the toxicities of this treatment in this patient population. OUTLINE: This is a multicenter study. Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression. PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.

Conditions

• Bladder Cancer
• Transitional Cell Cancer of the Renal Pelvis and Ureter
• Urethral Cancer

Interventions

Type	Name	Description
DRUG	rubitecan

Timeline

• Start date: 2000-05-01
• Primary completion: 2001-10-01
• First posted: 2004-03-16
• Last updated: 2012-09-24

Locations

11 sites across 7 countries: Belgium, France, Israel, Italy, Netherlands, Spain, Switzerland