Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M In BCG Refractory NMIBC
Status and phase
Terminated
Phase 3
Conditions
Non Muscle Invasive Bladder Cancer
Treatments
Drug: Nanoxel®M
Drug: Mitomycin-C
Details and patient eligibility
About
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.
Enrollment
36 patients
Sex
All
Ages
20+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
36 participants in 2 patient groups
Nanoxel®M
Experimental group
Description:
75 mg in 100mL normal saline
Treatment:
Drug: Nanoxel®M
Mitomycin
Active Comparator group
Description:
40 mg in 100mL normal saline
Treatment:
Drug: Mitomycin-C
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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