Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients
Status:
Terminated
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborators:
New York Presbyterian Hospital Weill Medical College of Cornell University