Official Title: “The Effect of Fluoroquinolones on the Disease-Free Interval in Patients With Stage Ta Transitional Cell Carcinoma of the Bladder”

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.

Study Type: Interventional

Study Design: Treatment, Randomized

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.

Intervention(s) in this Clinical Trial

• Drug: cephalexin
• Drug: ciprofloxacin
• Drug: trimethoprim-sulfamethoxazole
• Procedure: chemotherapy
• Procedure: surgical procedure

• DISEASE CHARACTERISTICS: Stage Ta (any grade) transitional cell carcinoma of the bladder on basis of cystoscopy Recurrent disease no greater than T1 Must not be at high risk for upper tract (ureter or renal pelvic) transitional cell cancers
• PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other:
• Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancy in the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission No allergies to fluoroquinolones If allergic to penicillin or cephalosporin, must be able to take co-trimoxazole
• PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 28 days since prior intravesical therapy and recovered Endocrine therapy: Not specified
• Radiotherapy: At least 28 days since prior radiotherapy and recovered Surgery: Not specified Other: At least 3 months prior to cystoscopy since prior fluoroquinolones No concurrent fluoroquinolones No concurrent hemodialysis or peritoneal dialysis No concurrent probenecid or theophylline No concurrent antacids containing aluminum, magnesium or calcium, products containing iron or zinc, caffeine, cyclosporine, or warfarin

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Southwest Oncology Group

Overall Clinical Trial Officials and Contacts

David P. Wood, MD Study Chair Barbara Ann Karmanos Cancer Institute  

Information obtained from ClinicalTrials.gov on November 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00003824

Study ID Number: CDR0000066978

ClinicalTrials.gov Identifier: NCT00003824

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database