Bladder Cancer: 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)

Sponsor

Endo Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01316874

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

2.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma in Situ Bladder Cancer	Drug: Valrubicin, 800 mg	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Study Start Date :

Nov 1, 1993

Actual Primary Completion Date :

Apr 1, 1997

Actual Study Completion Date :

Apr 1, 1997

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AD32 (valrubicin) 800mg, once weekly for 6 weeks	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.

Arm

Intervention/Treatment

Experimental: AD32 (valrubicin)

800mg, once weekly for 6 weeks

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.

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

To evaluate the qualitative toxicities associated with intravesical therapy using AD 32 (valrubicin). [6 weeks]
To determine the concentration of anthracyclines in the voided urine of patients who chose to participate in a urine recovery study. [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion-

Patients must have pathologically-proven CIS with no evidence of muscle invasive disease.
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.
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).
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.
Patients must have an ECOG performance status of 0-2 and a life expectancy of at least 6 months.

Exclusion-

Patients with urogenital tumors with histology other than transitional cell carcinoma
Patients with residual papillary disease at the time of study treatment.
Patients with a history of other primary malignancy (other than squamous or basal cell skin cancers) within the last 5 years.
Patients with evidence of muscle invasive disease (stage higher than T1).
Patients with any previous intravesical treatment with AD 32 (valrubicin).
Patients with any intravesical therapy within 28 days prior to first AD 32 (valrubicin) treatment.
Patients with a plan to receive other concurrent therapy for treatment of primary treatment tumor during participation in this study.
Patients who had received prior systemic or radiation therapy for bladder cancer.
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.
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.
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).

Contacts and Locations

Locations

	Site	City	State	Country
1	Stacy Childs, MD	Alabaster	Alabama	United States
2	William Bohnert, MD	Phoenix	Arizona	United States
3	Scott Swanson, MD	Scottsdale	Arizona	United States
4	Bruce Dalkin, MD	Tucson	Arizona	United States
5	Donald Gleason, MD	Tucson	Arizona	United States
6	William Friedel, MD	La Mesa	California	United States
7	Stephen Auerbach, MD	Newport Beach	California	United States
8	William Moseley, MD	San Diego	California	United States
9	Standley Brosman, MD	Santa Monica	California	United States
10	Eugene Dula, MD	Van Nuys	California	United States
11	B. Thomas Brown, MD	Daytona Beach	Florida	United States
12	Charles Jackson, MD	Ft. Lauderdale	Florida	United States
13	Marc Soloway, MD	Miami	Florida	United States
14	Charles Brendler, MD	Chicago	Illinois	United States
15	Patrick Guinan, MD	Chicago	Illinois	United States
16	Jeffrey Ignatoff, MD	Evanston	Illinois	United States
17	David Wood, MD	Lexington	Kentucky	United States
18	John Tuttle, MD	Lexington	Kentucky	United States
19	Dennis Venable, MD	Shreveport	Louisiana	United States
20	Harold Frazier, MD	Bethasda	Maryland	United States
21	Myron Murdock, MD	Greenbelt	Maryland	United States
22	John Libertino	Burlington	Massachusetts	United States
23	W. Lamar Weems, MD	Jackson	Mississippi	United States
24	Hugh Fisher, MD	Albany	New York	United States
25	Michael Blute, MD	Rochester	New York	United States
26	Michael Wolff, MD	Burlington	North Carolina	United States
27	Cary Robertson, MD	Durham	North Carolina	United States
28	Eric Klein, MD	Cleveland	Ohio	United States
29	Bruce Lowe, MD	Portland	Oregon	United States
30	Jeffrey Cohen, MD	Pittsburgh	Pennsylvania	United States
31	Jacques Susset, MD	Providence	Rhode Island	United States
32	L. Dean Knoll, MD	Nashville	Tennessee	United States
33	Steohen Hardeman, MD	Austin	Texas	United States
34	Ian Thompson, MD	Ft. San Houston	Texas	United States
35	Seth Lemer, MD	Houston	Texas	United States
36	Aaron Katz, MD	Richmond	Virginia	United States
37	Gary Katz, MD	Richmond	Virginia	United States
38	Williams Ellis, MD	Seattle	Washington	United States
39	Richard Boxer, MD	Milwaukee	Wisconsin	United States