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)

This study has been completed.
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01316874
First received: March 15, 2011
Last updated: March 16, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Carcinoma in Situ
Bladder Cancer
Other: PI discretion
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the qualitative toxicities associated with intravesical therapy using AD 32 (valrubicin). [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: November 1993
Study Completion Date: April 1997
Primary Completion Date: April 1997 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AD32 (valrubicin)
800mg, once weekly for 6 weeks
Other: PI discretion
Investigator will be responsible for regulating the use of concomitant medications (systemic and/or topical anticholinergic therapy or topical anesthesia) and other medications.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316874

  Show 39 Study Locations
Sponsors and Collaborators
Endo Pharmaceuticals
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sr. Director Clinical R&D, Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01316874     History of Changes
Other Study ID Numbers: A9301/A9302
Study First Received: March 15, 2011
Last Updated: March 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
Valrubicin
CIS
AD 32, BCG-refractory CIS
Carcinoma in situ (CIS) previously treated with BCG

Additional relevant MeSH terms:
Carcinoma
Carcinoma in Situ
Recurrence
Urinary Bladder Neoplasms
Disease Attributes
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pathologic Processes
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
BCG Vaccine
Valrubicin
Adjuvants, Immunologic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 21, 2014