BCG With or Without Mitomycin in Treating Patients With Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

A Randomized Phase II Trial of Sequential Chemo-Immunotherapy Versus Immunotherapy Alone in Carcinoma in Situ of the Urinary Bladder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00023842
• Other study ID #: EORTC-30993
• Secondary ID: EORTC-30993AURO-
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2001
• Last updated: September 20, 2012
• Start date: June 2001

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system and stop tumor cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with biological therapy may kill more tumor cells. It is not yet known if BCG is more effective with or without mitomycin.

PURPOSE: Randomized phase II trial to compare the effectiveness of BCG plus mitomycin with that of BCG alone in treating patients who have bladder cancer.

Description:

OBJECTIVES:

• Compare the complete response rate of patients with carcinoma in situ of the bladder treated with adjuvant intravesical BCG with or without intravesical mitomycin following transurethral resection.

• Compare the disease-free interval and type of recurrence after complete response in patients treated with these regimens.

• Compare the side effects of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of two treatment arms.

Arm I:

• Induction therapy: Patients receive intravesical mitomycin over 1 hour once weekly on weeks 1-6 and intravesical BCG once weekly on weeks 7-12. Patients with visible lesions or disease recurrence or progression undergo transurethral resection (TUR) during weeks 16-18 and receive one additional course of intravesical therapy.

• Maintenance therapy:Patients with a complete response after either course of induction therapy proceed to maintenance therapy comprising intravesical mitomycin once on week 1 and intravesical BCG once weekly on weeks 2 and 3. Maintenance therapy repeats every 6 months through year 3.

Arm II:

• Induction therapy:Patients receive intravesical BCG once weekly on weeks 1-6 and 10-12. Patients with visible lesions or disease recurrence or progression undergo transurethral resection (TUR) during weeks 16-18 and receive one additional course of intravesical therapy.

• Maintenance therapy: Patients with a complete response after either course of induction therapy receive maintenance therapy comprising intravesical BCG once weekly on weeks 1-3. Maintenance therapy repeats every 6 months through year 3.

Patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 84-126 patients (42-63 per treatment arm) will be accrued for this study within 3.5 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed carcinoma in situ (CIS) of the bladder with urinary cytology

• Primary CIS (no prior history of CIS, papillary, or solid transitional cell carcinoma [TCC] of the bladder and no concurrent papillary or solid TCC) OR

• Secondary CIS (detected after complete resection of superficial Ta/T1 TCC of the bladder) OR

• Concurrent CIS (in the presence of superficial primary or recurrent Ta/T1 TCC of the bladder)

• No more than 28 days since prior transurethral resection (TUR) of all visible lesions

• No muscle involvement

• No prior or concurrent upper urinary tract tumors

• No urethral strictures that would prevent endoscopic procedures and repeated catheterization

• No upper urinary tract disease (e.g., vesico-ureteral reflux or massive stones) that would make multiple transurethral procedures risky

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• Not pregnant or nursing

• No active tuberculosis (highly positive skin tests allowed if no active disease)

• No disease that would preclude general anesthesia

• No active intractable or uncontrollable infection

• No other prior or concurrent malignancy except cured basal cell skin cancer

• No psychological, familial, sociological, or geographical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior BCG

Chemotherapy:

• More than 3 months since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to the pelvis

Surgery:

• See Disease Characteristics

Other:

• More than 3 months since prior intravesical cytostatic agents

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Biological:
• BCG vaccine

Drug:
• mitomycin C

Procedure:
• adjuvant therapy

• conventional surgery

Locations

Country	Name	City	State
Belgium	Onze Lieve Vrouw Ziekenhuis Aalst	Aalst
Belgium	Academisch Ziekenhuis der Vrije Universiteit Brussel	Brussels
Belgium	Universitair Ziekenhuis Gent	Ghent
Belgium	Virga Jesse Hospital	Hasselt
Belgium	Cazk Groeninghe - Campus Maria's Voorzienigheid	Kortrijk
Italy	Azienda Ospedaliera Maggiore Della Carita	Novara
Italy	Universita Degli Studi Di Pisa	Pisa
Italy	Ospedale di Circolo e Fondazione Macchi	Varese
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Academisch Ziekenhuis Maastricht	Maastricht
Netherlands	University Medical Center Nijmegen	Nijmegen
Netherlands	Daniel Den Hoed Cancer Center at Erasmus Medical Center	Rotterdam
Portugal	Hospital Desterro	Amadora
Turkey	Dokuz Eylul University School of Medicine	Izmir
United Kingdom	Bristol Royal Infirmary	Bristol	England
United Kingdom	University of Wales College of Medicine	Cardiff	Wales

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  Italy,  Netherlands,  Portugal,  Turkey,  United Kingdom, 

References & Publications (1)

Oosterlinck W, Kirkali Z, Sylvester R, da Silva FC, Busch C, Algaba F, Collette S, Bono A. Sequential intravesical chemoimmunotherapy with mitomycin C and bacillus Calmette-Guérin and with bacillus Calmette-Guérin alone in patients with carcinoma in situ — View Citation