Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 and over NCI SWOG-S9809 CLB-S9809, NCT00003824, S9809

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.

Entry Criteria

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

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

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

Expected Enrollment

A total of 900 patients will be accrued for this study over 3 years.

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.

Wolman SR, Goldman B, Slovak ML, et al.: Aneusomy for detection of bladder cancer recurrence: a Southwest Oncology Group study. Cancer Genet Cytogenet 176 (1): 22-7, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

David Wood, MD, Protocol chair(Contact information may not be current)		Ph: 313-745-7381; 800-527-6266 Email: woodd@karmanos.org

Cancer and Leukemia Group B

David Wood, MD, Protocol chair(Contact information may not be current)		Ph: 313-745-7381; 800-527-6266 Email: woodd@karmanos.org

Registry Information
Official Title		The Effect of Fluoroquinolones on the Disease-Free Interval in Patients with Stage Ta Transitional Cell Carcinoma of the Bladder
Trial Start Date		1999-04-15
Registered in ClinicalTrials.gov		NCT00003824
Date Submitted to PDQ		1999-03-24
Information Last Verified		2007-07-05
NCI Grant/Contract Number		U10-CA32102