Intravesical AD 32 (Valrubicin) in Patients With Carcinoma in Situ (CIS) of the Bladder Who Have Failed or Have Recurrence Following Treatment With Bacillus Calmette-guerin (BCG)

Bladder Cancer Clinical Trial

— Bladder Cancer  

Official title:

Intravesical AD 32 (Valrubicin) in Patients With Carcinoma in Situ (CIS) of the Bladder Who Have Failed or Have Recurrence Following Treatment With Bacillus Calmette-Guerin (BCG)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01316874
• Other study ID #: A9301/A9302
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 15, 2011
• Last updated: June 10, 2015
• Start date: November 1993
• Est. completion date: April 1997

Study information

• Verified date: June 2015
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a Phase II/Phase III study of intravesical AD 32 (valrubicin) in patients with carcinoma in situ (CIS) who have been previously treated with intravesical Bacillus Calmette-Guerin (BCG) for CIS and in whom recurrence or failure has occurred after multiple courses of intravesical treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 1997
• Est. primary completion date: April 1997
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion-

1. Patients must have pathologically-proven CIS with no evidence of muscle invasive disease.

2. Patients with concurrent Ta or T1 papillary tumors are eligible provided papillary tumor(s) are resected prior to study treatment. Cystoscopic evaluation and, if indicated, transurethral resection of bladder tumor (TURBT) must be performed within 28 days of study treatment.

3. Patients must have received at least two or more prior courses of intravesical therapy for CIS per the recommended schedules. BCG must have been one of the prior therapies administered. Patients can have either failed BCG therapy or have been successfully treated with BCG, but subsequently found to have recurrence. The standard course of intravesical therapy must include six weekly treatments (allowable range of instillations per course is 4-9).

4. Patients must have a positive urine cytology at baseline (<28 days) prior to the first AD 32 (valrubicin) treatment. Patients with papillary lesions must have a positive cytology following TURBT or have a baseline cytology that was negative or equivocal and histologic confirmation of CIS.

5. Patients must have an ECOG performance status of 0-2 and a life expectancy of at least 6 months.

Exclusion-

1. Patients with urogenital tumors with histology other than transitional cell carcinoma

2. Patients with residual papillary disease at the time of study treatment.

3. Patients with a history of other primary malignancy (other than squamous or basal cell skin cancers) within the last 5 years.

4. Patients with evidence of muscle invasive disease (stage higher than T1).

5. Patients with any previous intravesical treatment with AD 32 (valrubicin).

6. Patients with any intravesical therapy within 28 days prior to first AD 32 (valrubicin) treatment.

7. Patients with a plan to receive other concurrent therapy for treatment of primary treatment tumor during participation in this study.

8. Patients who had received prior systemic or radiation therapy for bladder cancer.

9. Women who were pregnant or lactating. Individuals of reproductive potential could not participate unless agreeing to use an effective contraceptive method for themselves and/or their sexual partners.

10. Patients who, in the investigator's opinion, could not comply with the provisions of the protocol or did not understand the nature of the study.

11. Patients who, in the opinion of the investigator, could not tolerate intravesical administration of approximately 75 mL of fluid or who could not tolerate surgical manipulation (cystoscopy, mapping biopsies, barbotage) due to the presence of concomitant serious illnesses (ie, uncontrolled cardiac or respiratory disorders).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma
• Carcinoma in Situ

Intervention

Drug:
• Valrubicin, 800 mg
Investigator will be responsible for regulating the use of concomitant medications (systemic and/or topical anticholinergic therapy or topical anesthesia) and other medications.

Locations

Country	Name	City	State
United States	Stacy Childs, MD	Alabaster	Alabama
United States	Hugh Fisher, MD	Albany	New York
United States	Steohen Hardeman, MD	Austin	Texas
United States	Harold Frazier, MD	Bethasda	Maryland
United States	John Libertino	Burlington	Massachusetts
United States	Michael Wolff, MD	Burlington	North Carolina
United States	Charles Brendler, MD	Chicago	Illinois
United States	Patrick Guinan, MD	Chicago	Illinois
United States	Eric Klein, MD	Cleveland	Ohio
United States	B. Thomas Brown, MD	Daytona Beach	Florida
United States	Cary Robertson, MD	Durham	North Carolina
United States	Jeffrey Ignatoff, MD	Evanston	Illinois
United States	Charles Jackson, MD	Ft. Lauderdale	Florida
United States	Ian Thompson, MD	Ft. San Houston	Texas
United States	Myron Murdock, MD	Greenbelt	Maryland
United States	Seth Lemer, MD	Houston	Texas
United States	W. Lamar Weems, MD	Jackson	Mississippi
United States	William Friedel, MD	La Mesa	California
United States	David Wood, MD	Lexington	Kentucky
United States	John Tuttle, MD	Lexington	Kentucky
United States	Marc Soloway, MD	Miami	Florida
United States	Richard Boxer, MD	Milwaukee	Wisconsin
United States	L. Dean Knoll, MD	Nashville	Tennessee
United States	Stephen Auerbach, MD	Newport Beach	California
United States	William Bohnert, MD	Phoenix	Arizona
United States	Jeffrey Cohen, MD	Pittsburgh	Pennsylvania
United States	Bruce Lowe, MD	Portland	Oregon
United States	Jacques Susset, MD	Providence	Rhode Island
United States	Aaron Katz, MD	Richmond	Virginia
United States	Gary Katz, MD	Richmond	Virginia
United States	Michael Blute, MD	Rochester	New York
United States	William Moseley, MD	San Diego	California
United States	Standley Brosman, MD	Santa Monica	California
United States	Scott Swanson, MD	Scottsdale	Arizona
United States	Williams Ellis, MD	Seattle	Washington
United States	Dennis Venable, MD	Shreveport	Louisiana
United States	Bruce Dalkin, MD	Tucson	Arizona
United States	Donald Gleason, MD	Tucson	Arizona
United States	Eugene Dula, MD	Van Nuys	California

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Steinberg G, Bahnson R, Brosman S, Middleton R, Wajsman Z, Wehle M. Efficacy and safety of valrubicin for the treatment of Bacillus Calmette-Guerin refractory carcinoma in situ of the bladder. The Valrubicin Study Group. J Urol. 2000 Mar;163(3):761-7. Erratum in: J Urol. 2008 Jan;179(1):386. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the efficacy of AD 32 (valrubicin) in patients with CIS of the bladder who previously have been treated with BCG for CIS and in whom recurrence or failure had occurred after multiple courses of intravesical treatment.		12 weeks	No
Secondary	To evaluate the qualitative toxicities associated with intravesical therapy using AD 32 (valrubicin).		6 weeks	Yes
Secondary	To determine the concentration of anthracyclines in the voided urine of patients who chose to participate in a urine recovery study.		6 weeks	Yes