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Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the Bladder

Information source: Endo Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Carcinoma in Situ; Transitional Cell Carcinoma; Non-muscle Invasive Bladder Cancer

Intervention: VALSTAR - Maintenance Therapy (Drug); No Maintenance treatment ( Standard of Care) (Other)

Phase: Phase 3

Status: Terminated

Sponsored by: Endo Pharmaceuticals

Official(s) and/or principal investigator(s):
Philippe E Spiess, MD, MS, FACS, FRCS(C), Principal Investigator, Affiliation: H. Lee Moffitt Cancer Center and Research Institute

Summary

This is a Phase 3b open-label, randomized, parallel-arm, multicenter study to evaluate the efficacy and safety of 10 monthly intravesical administrations of maintenance therapy with valrubicin following induction with valrubicin as compared to induction with valrubicin only in subjects with CIS of the bladder. The randomization will be 1: 1 and subjects will be stratified by tumor type (CIS plus papillary disease vs. CIS only) and time from last bacillus Calmette-Guerin (BCG) failure (>1 year vs. <1 year).

Clinical Details

Official title: A PHASE 3B, RANDOMIZED, OPEN-LABEL, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MAINTENANCE THERAPY WITH VALRUBICIN VERSUS NO MAINTENANCE, IN SUBJECTS TREATED WITH VALRUBICIN INDUCTION FOR CARCINOMA IN SITU (CIS) OF THE BLADDER

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To Evaluate the Efficacy of Maintenance Therapy With Valrubicin After Induction With Valrubicin, as Compared to Induction With Valrubicin Only in Subjects With CIS of the Bladder.

Secondary outcome: To Evaluate the Safety and Tolerability of Maintenance Therapy With Valrubicin After Induction With Valrubicin, as Compared to Induction With Valrubicin Only in Subjects With CIS of the Bladder

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Is 18 years of age and older at time of consent signing 2. Have histologically confirmed diagnosis of CIS of the bladder and received valrubicin induction therapy per the labeled indication. 3. Is disease-free following induction with intravesical valrubicin

- Disease-free is defined as negative biopsy 10 to 12 weeks after the initiation

of valrubicin induction

- Valrubicin induction is defined as having received at least 3 of 6 weekly

instillations 4. Is available for the duration of the study including follow-up (minimum 12 months from randomization) 5. Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of 2 or less 6. Have no evidence of urothelial carcinoma involving the upper urinary tract or prostatic urethra (confirmed by extravesical work up, which may include radiological imaging and/or biopsy) within 6 months prior to randomization 7. Subjects (male and female) of child-bearing potential (including female subjects who are post-menopausal for less than 1 year) must be willing to practice abstinence or effective contraception (as defined by the investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment 8. Is able to understand and give written informed consent Exclusion Criteria: 1. Have current or previous history of muscle-invasive bladder cancer (MIBC) 2. Current or previous history of lymph node positive and/or metastatic bladder cancer 3. Have current evidence of pure squamous cell carcinoma, pure adenocarcinoma or pure undifferentiated carcinoma of the bladder 4. Is currently receiving systemic anti-cancer therapy (cytotoxic/cytostatic, immunotherapy or radiation) 5. Received treatment with an investigational agent within 30 days or 5 half-lives prior to randomization, whichever is longer 6. Received treatment with an intravesical chemotherapeutic agent (other than valrubicin or a single administration of mitomycin C post-transurethral resection of bladder tumor [TURBT]) within 3 months prior to randomization 7. Received treatment with valrubicin other than induction within 3 months prior to randomization 8. Have contraindication to valrubicin

- Known hypersensitivity to anthracyclines or polyoxyl castor oil

- Small bladder capacity, i. e. unable to tolerate a 75 mL instillation

- Concurrent urinary tract infection

9. Absolute neutrophil count (ANC) <1000/µL and hemoglobin <10 g/dL 10. Have active cardiovascular disease such as myocardial infarction within the past 3 months, unstable angina pectoris, congestive heart failure (NYHA Class III or IV) or uncontrolled cardiac arrhythmia 11. Female subjects who are pregnant or lactating 12. Subjects of childbearing potential who are unwilling to practice abstinence or effective contraception (as defined by investigator) during the study and for 30 days after last dose of study treatment 13. Have current or history of documented or suspected malignancy of any organ system (diagnosed, treated or untreated) within the past 5 years (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin and asymptomatic non-metastatic prostate cancer either previously successfully treated or currently under active surveillance or receiving hormone therapy only) 14. Is unable to tolerate intravesical administration or intravesical surgical manipulation (cystoscopy or biopsy) even with premedication 15. Have ongoing clinically significant active infections 16. Have any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial per protocol

Locations and Contacts

BCG Oncology, Phoenix, Arizona 85032, United States

The Urology Center of Colorado, Denver, Colorado 80211, United States

Urology Associates, Cumberland, Maryland 21502, United States

Delaware Valley Urology, Sewell, New Jersey 08080, United States

Associated Medical Professionals of New York, Syracuse, New York 13210, United States

Urologic Consultants of SE PA, Bala Cynwyd, Pennsylvania 19004, United States

Additional Information

Starting date: May 2011
Last updated: October 16, 2014

Page last updated: August 23, 2015

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