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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01316874
Recruitment Status : Completed
First Posted : March 16, 2011
Last Update Posted : June 12, 2015
Information provided by:
Endo Pharmaceuticals

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

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Study Type : Interventional  (Clinical Trial)
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 : November 1993
Actual Primary Completion Date : April 1997
Actual Study Completion Date : April 1997

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
Drug Information available for: Valrubicin

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.

Primary Outcome Measures :
  1. 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. [ Time Frame: 12 weeks ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  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.


  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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01316874

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Sponsors and Collaborators
Endo Pharmaceuticals
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sr. Director Clinical R&D, Endo Pharmaceuticals Identifier: NCT01316874    
Other Study ID Numbers: A9301/A9302
First Posted: March 16, 2011    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015
Keywords provided by Endo Pharmaceuticals:
AD 32, BCG-refractory CIS
Carcinoma in situ (CIS) previously treated with BCG
Additional relevant MeSH terms:
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Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Disease Attributes
Pathologic Processes
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action