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

NCT00974818 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-11-20

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Guido Dalbagni, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00974818 on ClinicalTrials.gov