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.
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 unresectable
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 very poor prognosis disease.
Cabazitaxel is a new taxane, taxanes have demonstrated activity in advanced bladder cancer,
and are among the most active new cytotoxic agents to be assessed in transitional cell
Cabazitaxel has demonstrated activity in cell lines with acquired resistance to doxorubicin,
vincristine, vinblastine, paclitaxel, and docetaxel.
This is a randomised, open-label, parallel-group phase 2 study of cabazitaxel versus best
supportive care (including 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
discontinuation visit taking place 3 weeks after last dose of treatment before the follow-up
This phase 2 study will initially recruit 25 patients and after interim analysis will to
increase to recruit 96 patients randomised between the two treatment options and the study
is expected to last about 2 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate
To compare the overall response rate of patients administered cabazitaxel vs best supportive care (including single agent chemotherapy) in patients with transitional cell carcinoma who have previously progressed on a platinum-based regimen.
Change from baseline at Week 9 and Week 18
University Hospitals Birmingham NHS FT
United Kingdom: National Health Service