A study to evaluate the effectiveness of combination cabazitaxel and cisplatin chemotherapy before surgery for invasive bladder cancer

• Conditions: Muscle invasive transitional cell carcinoma of the urinary bladder; MedDRA version: 14.1Level: PTClassification code 10066753Term: Bladder transitional cell carcinoma stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10005084Term: Bladder transitional cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10066754Term: Bladder transitional cell carcinoma stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-004090-82-GB
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust Research and Innovation Department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-14
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified