Muscle invasive transitional cell carcinoma of the urinary bladder MedDRA version: 14.1 Level: PT Classification code 10066753 Term: Bladder transitional cell carcinoma stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10005084 Term: Bladder transitional cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.
Conditions
Sponsors
University Hospitals Bristol NHS Foundation Trust Research and Innovation Department
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age =18 years; Histologically confirmed primary TCC of the urinary bladder; T2 to T4 disease, N0 M0 determined by CT imaging and biopsy or transurethral resection; ECOG Performance status 0 or 1; GFR =60ml/min; Written, informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: ECOG Performance Status = 2; Lymph node involvement or metastatic disease; Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrolment in the study; Active Grade =2 peripheral neuropathy; Active secondary cancers; History of severe hypersensitivity reaction (=Grade 3) to polysorbate 80 containing drugs; History of severe hypersensitivity reaction (=Grade 3) or intolerance to prednisone; Other concurrent serious illness or medical conditions; Inadequate organ function as evidenced by the following peripheral blood counts, and serum biochemistry at enrolment: Neutrophils =1.5 x 109/L, Haemoglobin =10 g/dL, Platelets =100 x 109/L, Total bilirubin > upper limit of normal (ULN), Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT)=2.5 x ULN, Alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT)=2.5 x ULN, Creatinine =1.5 x ULN; Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension, history of congestive heart failure, or myocardial infarction within last 6 months; Left ventricular ejection fraction =50%; 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 or inducers of cytochrome P450 3A4/5; Contraindications to cisplatin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To record the proportion of patients whose cancer responds to chemotherapy using the drugs cabazitaxel and cisplatin before surgery in the treatment of transitional cell carcinoma of the urinary bladder. This small study of about 30 patients will help to establish whether this treatment should be studied further in a larger group of patients in future.;Secondary Objective: To record side effects and tolerability of chemotherapy by regularly monitoring patients during and after the study, and recording any side effects experienced. To record the average survival of patients treated in the study. To assess quality of life during treatment.;Primary end point(s): Response rate (pathological partial response + complete response determined at radical cystectomy) with combination cisplatin and cabazitaxel chemotherapy in muscle invasive transitional cell carcinoma of the urinary bladder.;Timepoint(s) of evaluation of this end point: This endpoint is evaluated after participants have received 4 cycles of neoadjuvant combination chemotherapy with cabazitaxel and cisplatin, and have undergone subsequent radical cystectomy with histopathological assessment of response to neoadjuvant chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Safety and Quality of Life data are collected during chemotherapy treatment only and so will be evaluable after the final patient has completed study chemotherapy. Progression free and overall survival data are evaluable after 5 years' follow up (5 years after the final patient has undergone radical cystectomy);Secondary end point(s): Progression free survival, overall survival, Safety, Quality of life | — |
Countries
United Kingdom
Contacts
Public ContactDr Susan Masson
University Hospitals Bristol NHS Foundation Trust (Bristol Haematology and Oncology Centre)
Outcome results
None listed