Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients
NCT ID: NCT00974818
Last Updated: 2015-11-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE3
50 participants
INTERVENTIONAL
2009-09-30
2012-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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New York Presbyterian Hospital
OTHER
Weill Medical College of Cornell University
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Guido Dalbagni, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Weill Medical College of Cornell University
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Memorial Sloan-Kettering Cancer Center
Other Identifiers
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09-118
Identifier Type: -
Identifier Source: org_study_id