NCT00003824

S9809, Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer

The Effect of Fluoroquinolones on the Disease-Free Interval in Patients With Stage Ta Transitional Cell Carcinoma of the Bladder

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known whether ciprofloxacin is more effective than cephalexin in preventing cancer recurrence in patients who are undergoing surgery to treat bladder cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of ciprofloxacin with that of cephalexin in preventing recurrence of cancer in patients who are undergoing surgery for bladder cancer.

Detailed description

OBJECTIVES: I. Determine whether ciprofloxacin improves the recurrence-free survival of patients with superficial transitional cell carcinoma of the bladder treated with a transurethral tumor resection. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease status (first occurrence vs recurrent disease). Patients are randomized to receive either oral ciprofloxacin or oral cephalexin 2 times a day for 3 days starting the night before resection. Patients who are allergic to penicillin or a cephalosporin receive oral co-trimoxazole 2 times a day for 3 days. All patients undergo complete resection of all bladder tumors. Patients are followed every 3 months for the first 2 years, every 6 months for the next 2 years, and at the end of the fifth year. PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study over 3 years.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	cephalexin	500 mg oral bid for 3 days starting the night before resection
PROCEDURE	surgical procedure
DRUG	Ciprofloxacin	500 mg oral bid for 3 days starting the night before resection

Timeline

• Start date: 1999-04-01
• Primary completion: 2001-07-01
• Completion: 2007-01-01
• First posted: 2004-04-14
• Last updated: 2012-03-09

Locations

90 sites across 1 country: United States