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)

NCT ID: NCT01316874

Last Updated: 2015-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1993-11-30
• Study Completion Date: 1997-04-30

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.

Conditions

Carcinoma in Situ; Bladder Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AD32 (valrubicin)

800mg, once weekly for 6 weeks

Group Type: EXPERIMENTAL

Valrubicin, 800 mg

Intervention Type: DRUG

Investigator will be responsible for regulating the use of concomitant medications (systemic and/or topical anticholinergic therapy or topical anesthesia) and other medications.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Endo Pharmaceuticals

Locations

Stacy Childs, MD

Alabaster, Alabama, United States

William Bohnert, MD

Phoenix, Arizona, United States

Scott Swanson, MD

Scottsdale, Arizona, United States

Bruce Dalkin, MD

Tucson, Arizona, United States

Donald Gleason, MD

Tucson, Arizona, United States

William Friedel, MD

La Mesa, California, United States

Stephen Auerbach, MD

Newport Beach, California, United States

William Moseley, MD

San Diego, California, United States

Standley Brosman, MD

Santa Monica, California, United States

Eugene Dula, MD

Van Nuys, California, United States

B. Thomas Brown, MD

Daytona Beach, Florida, United States

Charles Jackson, MD

Fort Lauderdale, Florida, United States

Marc Soloway, MD

Miami, Florida, United States

Charles Brendler, MD

Chicago, Illinois, United States

Patrick Guinan, MD

Chicago, Illinois, United States

Jeffrey Ignatoff, MD

Evanston, Illinois, United States

David Wood, MD

Lexington, Kentucky, United States

John Tuttle, MD

Lexington, Kentucky, United States

Dennis Venable, MD

Shreveport, Louisiana, United States

Harold Frazier, MD

Bethasda, Maryland, United States

Myron Murdock, MD

Greenbelt, Maryland, United States

John Libertino

Burlington, Massachusetts, United States

W. Lamar Weems, MD

Jackson, Mississippi, United States

Hugh Fisher, MD

Albany, New York, United States

Michael Blute, MD

Rochester, New York, United States

Michael Wolff, MD

Burlington, North Carolina, United States

Cary Robertson, MD

Durham, North Carolina, United States

Eric Klein, MD

Cleveland, Ohio, United States

Bruce Lowe, MD

Portland, Oregon, United States

Jeffrey Cohen, MD

Pittsburgh, Pennsylvania, United States

Jacques Susset, MD

Providence, Rhode Island, United States

L. Dean Knoll, MD

Nashville, Tennessee, United States

Steohen Hardeman, MD

Austin, Texas, United States

Ian Thompson, MD

Fort San Houston, Texas, United States

Seth Lemer, MD

Houston, Texas, United States

Aaron Katz, MD

Richmond, Virginia, United States

Gary Katz, MD

Richmond, Virginia, United States

Williams Ellis, MD

Seattle, Washington, United States

Richard Boxer, MD

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 10687972 (View on PubMed)

Steinberg GD, Smith ND, Ryder K, Strangman NM, Slater SJ. Factors affecting valrubicin response in patients with bacillus Calmette-Guerin-refractory bladder carcinoma in situ. Postgrad Med. 2011 May;123(3):28-34. doi: 10.3810/pgm.2011.05.2281.

Reference Type: DERIVED

PMID: 21566413 (View on PubMed)

Other Identifiers

A9301/A9302

Identifier Type: -

Identifier Source: org_study_id