Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients

This study has been completed.
Sponsor:
Collaborators:
New York Presbyterian Hospital
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00974818
First received: September 9, 2009
Last updated: August 21, 2012
Last verified: August 2012

September 9, 2009
August 21, 2012
September 2009
March 2012   (final data collection date for primary outcome measure)
To test non-inferiority of intravesical chemo using optimized dose of MMC to intravesical BCG immunotherapy in the prevention of bladder cancer recurrence at 2 years among non-muscle-invasive UBC patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To test non-inferiority of intravesical chemo using optimized dose of MMC to intravesical TheracysR BCG immunotherapy in the prevention of bladder cancer recurrence at 2 years among non-muscle-invasive UBC patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00974818 on ClinicalTrials.gov Archive Site
  • To investigate the efficacy of intravesical chemotherapy using optimized dose of MMC versus intravesical BCG immunotherapy in the prevention of bladder cancer progression or radical cystectomy at 2 years among non-muscle-invasive UBC patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To evaluate the adverse events related to intravesical MMC and intravesical BCG in patients with UBC receiving induction followed by maintenance schedule. [ Time Frame: Assessment of toxicity prior to each administration of chemotherapy ] [ Designated as safety issue: Yes ]
  • To investigate the efficacy of intravesical chemotherapy using optimized dose of MMC versus intravesical TheracysR BCG immunotherapy in the prevention of bladder cancer progression or radical cystectomy at 2 years among non-muscle-invasive UBC patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To evaluate the adverse events related to intravesical MMC and intravesical TheracysR BCG in patients with UBC receiving induction followed by maintenance schedule. [ Time Frame: Assessment of toxicity prior to each administration of chemotherapy ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients
Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients: A Randomized Phase III Non-inferiority Trial

The purpose of this study is to compare the bladder cancer treatments, Mitomycin C (MMC) and Bacillus Calmette Guerin (BCG), to find out which is better. In this study, the patient will get either the Mitomycin C (MMC) or the Bacillus Calmette Guerin (BCG). They will not get both.

The patient had a Transurethral Resection (TUR) or an in office cystoscopy to make the diagnosis of bladder cancer. A biopsy was done and removed any tumors the doctor saw. Even after the doctor removes the tumors, the cancer can return. In this case, the doctor will put medicine into the bladder to destroy cancer cell. This is called intravesical therapy. The two most commonly used drugs for this purpose are MMC and BCG.

Both drugs have been studied for many years. They both show good results when compared to other treatments. They have not been studied using the schedule that will be used in the study. The doctor does not know if these two drugs are equally effective in treating the cancer and preventing recurrence.

BCG has been studied more often than MMC. The studies have shown that a long schedule of BCG is better than a short schedule of MMC. They have also shown that the side effects of BCG are more intense than with MMC. A recent study showed that a new dose of MMC is better than the old standard dose. Since the side effects of MMC occur less often, it is important to learn whether the two drugs are equally effective. That could help us decide between the treatments. In this study, the doctor will compare MMC and BCG when given for the same amount of time. The doctor hopes the study will tell us which drug is more effective in preventing the return of the cancer.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Bladder Cancer
  • Drug: Mitomycin C (MMC)
    Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course.
  • Biological: Bacillus Calmette-Guerin (BCG)
    Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course.
  • Experimental: pts getting Mitomycin C (MMC)
    Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.
    Intervention: Drug: Mitomycin C (MMC)
  • Experimental: pts getting Bacillus Calmette-Guerin (BCG)
    Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.
    Intervention: Biological: Bacillus Calmette-Guerin (BCG)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 years or older
  • Patients must have pathologically confirmed non-muscle invasive urothelial bladder carcinoma by the Department of Pathology New York Presbyterian Hospital, Weill Medical College of Cornell University or Memorial Sloan Kettering Cancer Center or a documented past history of Ta or T1 non-muscle invasive urothelial bladder tumors.
  • Intermediate Risk UBC patients: Recurrence Total Score = 1 to 9

Exclusion Criteria:

  • Any intravesical therapy within the past six months prior to current diagnosis
  • Currently being treated or scheduled to have radiation treatment for bladder cancer during the study
  • Scheduled to have surgery for bladder cancer during the study
  • Currently being treated or scheduled to have treatment with any chemotherapeutic agent during the study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00974818
09-118
Yes
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • New York Presbyterian Hospital
  • Weill Medical College of Cornell University
Principal Investigator: Guido Dalbagni, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP