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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-08-31

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.

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Detailed Description

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Conditions

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Non Muscle Invasive Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nanoxel®M

75 mg in 100mL normal saline

Group Type EXPERIMENTAL

Nanoxel®M

Intervention Type DRUG

Intravesical

Mitomycin

40 mg in 100mL normal saline

Group Type ACTIVE_COMPARATOR

Mitomycin-C

Intervention Type DRUG

Intravesical

Interventions

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Nanoxel®M

Intravesical

Intervention Type DRUG

Mitomycin-C

Intravesical

Intervention Type DRUG

Other Intervention Names

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Polysorbate 80, ethanol free Docetaxel

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No