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

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

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.

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