Chemotherapy in Treating Patients With Early-Stage Bladder Cancer
|ClinicalTrials.gov Identifier: NCT00003129|
Recruitment Status : Completed
First Posted : April 18, 2003
Last Update Posted : June 9, 2009
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 chemotherapy in treating patients with early-stage bladder cancer that has not responded to BCG therapy.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: valrubicin||Phase 2|
- Determine the recurrence rate and disease free survival in patients with recurrent or refractory papillary transitional cell carcinoma of the bladder with or without carcinoma in situ of the bladder treated with intravesical AD 32.
- Evaluate the safety of administering this drug in these patients.
- Determine the effectiveness of this drug, in terms of recurrence rates and disease free survival, in these patients.
OUTLINE: Patients are stratified according to cellular diagnosis (papillary transitional cell carcinoma (Ta/T1) with no carcinoma in situ (Tis) vs Tis with or without Ta/T1).
Patients receive intravesical AD 32 once a week for 6 weeks.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Official Title:||Phase II Study of Intravesical Therapy With AD 32 in Patients With Papillary Urothelial Carcinoma or Carcinoma in Situ (CIS) Refractory to Prior Therapy With Bacillus Calmette-Guerin|
|Study Start Date :||July 1998|
|Primary Completion Date :||November 2002|
U.S. FDA Resources
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003129
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612-9497|
|United States, Illinois|
|CCOP - Carle Cancer Center|
|Urbana, Illinois, United States, 61801|
|United States, New Jersey|
|Veterans Affairs Medical Center - East Orange|
|East Orange, New Jersey, United States, 07018-1095|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|CCOP - MainLine Health|
|Wynnewood, Pennsylvania, United States, 19096|
|United States, Wisconsin|
|CCOP - Green Bay|
|Green Bay, Wisconsin, United States, 54301|
|Veterans Affairs Medical Center - Madison|
|Madison, Wisconsin, United States, 53705|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792-6164|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Veterans Affairs Medical Center - Milwaukee (Zablocki)|
|Milwaukee, Wisconsin, United States, 53295|
|Study Chair:||Jeffrey M. Ignatoff, MD||NorthShore University HealthSystem Research Institute|