NCT01830231

Cabazitaxel vs. Vinflunine in Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium (TCCU)

A Randomised Phase II/III Study of Cabazitaxel Versus Vinflunine in Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 372 (estimated)
• Sponsor: Associació per a la Recerca Oncologica, Spain · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Due to limited experience with cabazitaxel in TCCU, the study will be started as a randomised phase II study. The aim of the phase II study is to evaluate if the response rates (CR + PR) are sufficiently high to further study the treatment regimens in a phase III setting.

Detailed description

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: (Randomize 1:1) * 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 progression

Conditions

• Urothelium Transitional Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cabazitaxel	Cabazitaxel, to be given intravenously once every 21 days, starting at a dose of 25 mg/m2 as a 1-hour intravenous infusion.
DRUG	Vinflunine	Vinflunine, to be given intravenously once every 21 days, as a 20 minute intravenous infusion, starting at a dose of: * 320 mg/m2 in patients aged ≤75 years with PS 0 and no prior pelvic radiation, and of * 280 mg/m2 in patients aged \>75 - ≤80 years or with PS 1 or prior pelvic radiation, * 250 mg/m2 in patients aged \>80 years.

Timeline

• Start date: 2012-10-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2013-04-12
• Last updated: 2014-01-28

Locations

20 sites across 2 countries: Netherlands, Spain