Treatment of Locally Advanced or Metastatic Transitional Cell Carcinoma With Cabazitaxel (CabB1)
A study for patients with confirmed locally advanced or metastatic Transitional Cell Carcinoma of the bladder or upper urinary tracts who have developed progressive disease within 12 months of their platinum based chemotherapy. The study aims to compare the overall response rate of cabazitaxel treatment versus best supportive care including single agent chemotherapy.
Transitional Cell Carcinoma
Other: Best Supportive Care
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official 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.|
- Overall response rate [ Time Frame: Change from baseline at Week 9 and Week 18 ] [ Designated as safety issue: No ]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.
- Overall survival [ Time Frame: From date of randomisation to the date of tumour progression or death (from any cause) (or survival at study cut-off date), whichever came first up to 12months after the final patient has completed study treatment ] [ Designated as safety issue: No ]Defined as the time interval from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time will be censored at the earlier of the last date the patient is known to be alive and the study cut-off date.
- Quality of Life [ Time Frame: Change from baseline at Week 6, Week 12, Week 18, Week 21 ] [ Designated as safety issue: No ]QOL will be assessed by using a validated instrument; the EuroQOL (EQ-5D).
- Safety and tolerability [ Time Frame: From date of randomisation up to 30 days after final dose of study medication ] [ Designated as safety issue: Yes ]Dose delays and dose reductions, adverse events, laboratory safety data
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
6 cycles (3 weekly) of 25 mg/m^2 IV infusion
25 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: maximum 6
Other Name: Jevtana, XRP6258, RPR116258A
Best Supportive Care
Best supportive care including single agent chemotherapy as determined by the patient's study doctor
Other: Best Supportive Care
Best Supportive Care including single agent chemotherapy as determined by the patient's study physician
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 disease.
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 carcinoma.
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 phase begins.
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.
|Contact: Anjali Zarkar, MD MBBS||+44 121 371 email@example.com|
|Contact: Amanda Davies, BSc (Hons)||+44 121 204 firstname.lastname@example.org|
|University Hospitals Birmingham||Recruiting|
|Birmingham, United Kingdom, B15 2TH|
|Principal Investigator: Anjali Zarkar, MRCP MD FRCR|
|Sub-Investigator: Nicholas James, MBBSFRCP PhD|
|Principal Investigator:||Anjali Zarkar||University Hospitals Birmingham NHS FT|