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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01316874
Other study ID # A9301/A9302
Secondary ID
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


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
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