A Randomised Phase II/III Study of Cabazitaxel Versus Vinflunine in Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium
Once it is confirmed that the subjects fulfil the eligibility criteria and have signed the
informed consent, they will be randomised to receive treatment based on cabazitaxel or
vinflunine according to the following study schema:
- Cabazitaxel 25 mg/m2 q3w
- Vinflunine 250-320 mg/m2 q3w
Random assignment of treatment will be stratified by the presence of 0 versus 1 of the
following unfavourable prognostic risk factors proposed recently by Bellmunt et al. (1):
- Eastern Cooperative Oncology Group (ECOG) PS 1.
- Anaemia with Hb <10 g/dL.
- Presence of liver metastases.
All patients enrolled in the study will receive a cycle of treatment with the study
medication (cabazitaxel or vinflunine) every 21 days until disease progression or
intolerable/unacceptable toxicity. Tumour evaluations will be scheduled every 6 weeks until
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase II main objective: to assess the efficacy of cabazitaxel compared to vinflunine in terms of improved objective response rate (ORR) of subjects with metastatic or locally advanced previously treated TCCU.
Efficacy of cabazitaxel compared to vinflunine on terms of improved objective response rate (ORR)
From date of randomization to disease progression or until 18 months from enrolment.
Joaquim Bellmunt, MD/PhD
Spain: Spanish Agency of Medicines