Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M In BCG Refractory NMIBC (NCT02982395) | Clinical Trial Compass
TerminatedPhase 3
Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M In BCG Refractory NMIBC
South Korea36 participantsStarted 2017-01
Plain-language summary
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.
Who can participate
Age range20 Years
SexALL
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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