A Phase II Trial of Combination Cabazitaxel and Cisplatin Chemotherapy in the Neo-adjuvant Treatment of Transitional Cell Carcinoma of the Urinary Bladder
Inclusion Criteria:
- Age ≥18 years
- Histologically confirmed primary transitional cell carcinoma (TCC) of the urinary
bladder
- T2 to T4 disease, N0 M0 determined by computerised tomography (CT) imaging and biopsy
or transurethral resection
- Eastern Co-operative Oncology Group (ECOG) Performance status 0 or 1
- Glomerular filtration rate (GFR) ≥60ml/min.
- Written, informed consent
Exclusion Criteria
- ECOG Performance Status ≥ 2
- Lymph node involvement or metastatic disease
- Prior surgery (except transurethral resection of bladder tumour), radiation,
che-motherapy, or other anti-cancer therapy within 4 weeks prior to enrolment
- Active Grade ≥2 peripheral neuropathy
- Active secondary cancers
- History of severe hypersensitivity reaction (≥Grade 3) to polysorbate 80 containing
drugs
- Other concurrent serious illness or medical conditions
- Inadequate organ function as evidenced by peripheral blood counts at enrolment:
- Electrocardiogram (ECG) evidence of uncontrolled cardiac arrhythmias, angina
pectoris, and/or hypertension, history of congestive heart failure, or myocardial
infarction within last 6 months.
- Uncontrolled diabetes mellitus.
- Active uncontrolled gastro-oesophageal reflux disease (GORD).
- Active infection requiring systemic antibiotic or anti-fungal medication
- Participation in another clinical trial with any investigational drug within 30 days
prior to study enrolment.
- Concurrent or planned treatment with strong inhibitors of cytochrome P450 3A4/5. A
1-week washout period is necessary for patients who are already on these treatments.
- Concurrent or planned treatment with strong inducers of cytochrome P450 3A4/5. A
1-week washout period is necessary for patients who are already on these treatments.
- Contraindications to cisplatin.
- Patient with reproductive potential not implementing an accepted and effective method
of contraception.