Cab B1
Research type
Research Study
Full title
Cabazitaxel in platinum pre-treated patients with locally advanced or metastatic transitional cell carcinoma who developed disease progression within 12 months of platinum based chemotherapy.
IRAS ID
105633
Contact name
Anjali Zarkar
Sponsor organisation
University Hospitals Birmingham NHS Foundation Trust
Eudract number
2012-002552-16
Clinicaltrials.gov Identifier
Research summary
A study for patients with confirmed locally advanced or metastatic Transitional Cell Carcinoma (TCC) of the bladder or upper urinary tracts whose disease has progressed within 12 months of receiving platinum based chemotherapy. Bladder cancer was the 9th most common cause of cancer worldwide in 2002. About 70% of patients have superficial tumour and 30% have invasive tumour at diagnosis. Patients with superficial tumour are treated by surgery, which is the only curative treatment. However, about 50% of these patients will relapse, and cannot be cured by local treatment in the majority of cases. The survival of untreated metastatic patients does not exceed 3 to 6 months, and systemic chemotherapy increases overall survival of patients with disease that cannot be surgically removed. However, the overall survival of patients with advanced disease treated with chemotherapy remains short (14 months), which reflects a substantial unmet medical need for more effective therapy in this disease with a very poor prognosis. Cabazitaxel is a new chemotherapy drug (a taxane) which has demonstrated activity in advanced bladder cancer cell lines with acquired resistance to other chemotherapy agents (e.g. vincristine and docetaxel), and are among the most active new chemotherapy drugs to be assessed in TCC. This study is a randomised, open-label, parallel-group phase 2 study of cabazitaxel versus best supportive care (including single agent chemotherapy). The study is divided into three phases: screening, treatment, and follow-up. The treatment phase comprises a maximum of six three-weekly cycles of therapy, with a post treatment visit 3 weeks after last dose before the follow-up phase begins. Patients will be followed-up until death or until 12 months after the final patient has received their last dose of study medication.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
12/EM/0363
Date of REC Opinion
11 Oct 2012
REC opinion
Favourable Opinion