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

Bladder Cancer Clinical Trial

Official title:

Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients: A Randomized Phase III Non-inferiority Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00974818
• Other study ID #: 09-118
• Status: Terminated
• Phase: Phase 3
• First received: September 9, 2009
• Last updated: October 20, 2015
• Start date: September 2009
• Est. completion date: March 2012

Study information

• Verified date: October 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Weill Medical College of Cornell University	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	New York Presbyterian Hospital, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to Treatment	will be assessed by cystoscopy every 3 months (+/- 3 weeks) in the first 2 years after induction.	2 years	No

External Links

•   Memorial Sloan-Kettering Cancer Center