Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M In BCG Refractory NMIBC

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Nanoxel®M is effective in the treatment of patients with recurrent Ta and T1 who experienced treatment failure with at least one prior BCG intravesical treatment.

Official Title
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A Phase Ⅲ Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M (Docetaxel-PM) In Bacillius Calmette-Guerin Refractory Non-Muscle Invasive Bladder Cancer

Conditions
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Non Muscle Invasive Bladder Cancer

Intervention / Treatment
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* Drug: Nanoxel®M
* Drug: Mitomycin-C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed diagnosis of superficial transitional cell carcinoma of the bladder (Ta, T1) Recurrent superficial bladder cancer refractory to Bacillus Calmette-Guerin (BCG) No previous intravesical therapy for 6 weeks No history of prior radiation to the pelvis Peripheral neuropathy ≤ grade 1 Eastern Cooperative Oncology Group (ECOG) performance status 0 t0 2 Adequate hematopoietic and hepatic parameters Exclusion Criteria: Muscle invasive disease (T2-T4) Any other malignancy diagnosed within 2 years of study entry (Except basal or squamous cell skin cancers or noninvasive cancer of the cervix) Participation in any other research protocol involving administration of an investigational agent within 3 months before study entry History of sensitivity reaction to docetaxel Prescribed immunosuppressive medications because of a confounding medical condition Female patients who were pregnant or lactating

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nanoxel®M<br>75 mg in 100mL normal saline | Drug: Nanoxel®M<br>* Intravesical<br>* Other names: Polysorbate 80, ethanol free Docetaxel;|
| Active Comparator: Mitomycin<br>40 mg in 100mL normal saline | Drug: Mitomycin-C<br>* Intravesical<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence free rate | Recurrence free rate will be summarized as the percentage of participants who achieved a confirmed recurrence free as assessed by urine cytology and cystoscopy. Recurrence means reappearance of high-risk disease (high grade, T1 or CIS) after the start of therapy. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence free rate | Recurrence free rate will be summarized as the percentage of participants who achieved a confirmed recurrence free as assessed by urine cytology and cystoscopy.Recurrence means reappearance of high-risk disease (high grade, T1 or CIS) after the start of therapy. | 6 months, 2 years | 
| Overall survival | Time from random assignment to death resulting from any cause. | 2 years | 
| Number of participants with adverse events as assessed by CTCAE v4.0 | Adverse event (AE) is as any AE occurring or worsening from the first treatment of any study drug to the last dose of the last study drug. Severity grades according to NCI CTCAE version 4.0. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nanoxel M, Docetaxel PM, Docetaxel, Mitomycin C, BCG, BCG refractory, Non muscle invasive bladder cancer, intravesical, superficial bladder cancer, Urothelial carcinoma, Transitional cell carcinoma