NCT00002914

Piritrexim in Treating Patients With Advanced Cancer of the Urinary Tract

PHASE II STUDY OF PIRITREXIM IN ADVANCED CARCINOMA OF THE UROTHELIUM

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: All
• Age: 18 Years – 120 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 piritrexim in treating patients with advanced cancer of the urinary tract that has not responded to previous treatment.

Detailed description

OBJECTIVES: I. Evaluate the antineoplastic activity of piritrexim and its effect on the survival of patients with advanced urothelial carcinoma previously treated with systemic cytotoxic chemotherapy. II. Evaluate the toxicity of piritrexim in these patients. OUTLINE: Patients receive piritrexim by mouth 3 times daily, 5 days a week, for 3 weeks followed by 1 week of rest. Patients with responding or stable disease continue treatment every 4 weeks until unacceptable toxicity or progression intervenes. PROJECTED ACCRUAL: A maximum of 40 patients will be entered over 5-6 months if at least 1 response is observed in the first 14 evaluable patients.

Conditions

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

Interventions

Type	Name	Description
DRUG	piritrexim

Timeline

• Start date: 1997-07-15
• Primary completion: 2001-06-01
• Completion: 2004-03-01
• First posted: 2004-08-11
• Last updated: 2023-06-22

Locations

29 sites across 2 countries: United States, South Africa