Piritrexim in Treating Patients With Advanced Cancer of the Urinary Tract

NCT ID: NCT00002914


Title
PHASE II STUDY OF PIRITREXIM IN ADVANCED CARCINOMA OF THE UROTHELIUM
Purpose
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.
Details
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
Keywords
recurrent bladder cancer, transitional cell carcinoma of the bladder, squamous cell carcinoma of the bladder, adenocarcinoma of the bladder, recurrent urethral cancer, recurrent transitional cell cancer of the renal pelvis and ureter
Source
Eastern Cooperative Oncology Group
Sponsors
Eastern Cooperative Oncology Group, National Cancer Institute (NCI)
Status
Completed
Acronym
Last Updated
24 Jan 2010
URL
Official Link
Citations/Publications
Roth BJ, Manola J, Dreicer R, Graham D, Wilding G; Eastern Cooperative Oncology Group.. Piritrexim in advanced, refractory carcinoma of the urothelium (E3896): a phase II trial of the Eastern Cooperative Oncology Group. Invest New Drugs. 2002 Nov;20(4):425-9.

Locations
South Africa, United States