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)
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|ClinicalTrials.gov Identifier: NCT01316874|
Recruitment Status : Completed
First Posted : March 16, 2011
Last Update Posted : June 12, 2015
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|Condition or disease||Intervention/treatment||Phase|
|Carcinoma in Situ Bladder Cancer||Drug: Valrubicin, 800 mg||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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 ]
- To evaluate the qualitative toxicities associated with intravesical therapy using AD 32 (valrubicin). [ Time Frame: 6 weeks ]
- 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 ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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).
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 ClinicalTrials.gov identifier (NCT number): NCT01316874
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Sr. Director Clinical R&D, Endo Pharmaceuticals|
|Other Study ID Numbers:||
|First Posted:||March 16, 2011 Key Record Dates|
|Last Update Posted:||June 12, 2015|
|Last Verified:||June 2015|
AD 32, BCG-refractory CIS
Carcinoma in situ (CIS) previously treated with BCG
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Topoisomerase II Inhibitors
Molecular Mechanisms of Pharmacological Action