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
NCT ID: NCT01310803
Last Updated: 2017-10-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
1 participants
INTERVENTIONAL
2011-05-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Maintenance therapy
Chemotherapeutic: EN3329-301 (VALSTAR)
VALSTAR - Maintenance Therapy
Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase
No Maintenance (Standard of care)
Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy
No Maintenance treatment ( Standard of Care)
Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy
Interventions
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VALSTAR - Maintenance Therapy
Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase
No Maintenance treatment ( Standard of Care)
Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Endo Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Philippe E Spiess, MD, MS, FACS, FRCS(C)
Role: PRINCIPAL_INVESTIGATOR
H. Lee Moffitt Cancer Center and Research Institute
Locations
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BCG Oncology
Phoenix, Arizona, United States
The Urology Center of Colorado
Denver, Colorado, United States
Urology Associates
Cumberland, Maryland, United States
Delaware Valley Urology
Sewell, New Jersey, United States
Associated Medical Professionals of New York
Syracuse, New York, United States
Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania, United States
Countries
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Other Identifiers
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EN3329-301
Identifier Type: -
Identifier Source: org_study_id