Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer
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|ClinicalTrials.gov Identifier: NCT00003175|
Recruitment Status : Completed
First Posted : April 30, 2004
Last Update Posted : December 4, 2013
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 fluorouracil given as a continuous infusion in treating patients with recurrent or metastatic bladder cancer.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer||Drug: fluorouracil||Phase 2|
OBJECTIVES: I. Determine the response rate and toxic effects of continuous fluorouracil in patients with recurrent locally advanced or metastatic transitional cell urinary tract carcinoma. II. Determine the feasibility of this treatment in this patient population.
OUTLINE: Patients receive continuous intravenous fluorouracil by a Baxter Infusor for 24 weeks. Patients are evaluated for complete and partial response at 8, 16, and 24 weeks after the start of intravenous fluorouracil. Patients experiencing disease progression or unacceptable toxic effects are removed from the study. Patients are followed monthly for 6 months post treatment.
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Official Title:||A Phase II Study of Continuous 5-Fluorouracil (5-FU) in Recurrent Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urinary Tract|
|Study Start Date :||December 1997|
|Actual Study Completion Date :||March 2009|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003175
|Study Chair:||Peter G. Harper, MD||St. Thomas' Hospital|