Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

Cabazitaxel 25 mg/m2 q3w. Cabazitaxel will be given intravenously once every 21 days, starting at a dose of 25 mg/m2 as a 1-hour intravenous infusion

• Vinflunine will be given intravenously once every 21 days, starting at a dose of:

* 320 mg/m2 in patients aged ≤75 years with PS 0 and no prior pelvic radiation
* 280 mg/m2 in patients aged \>75 - ≤80 years, and/or with PS 1 and/or prior pelvic radiation,
* 250 mg/m2 in patients aged \>80 years.

Cabazitaxel, to be given intravenously once every 21 days, starting at a dose of 25 mg/m2 as a 1-hour intravenous infusion.

Cabazitaxel

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.

Vinflunine

Joaquim Bellmunt, MD/PhD

Inmaculada Musté

Martijn Kerst, MD

van den Eertwegh, MD

Maartje Los, MD

Ronald De witt, MD, PHD

Urbano Anido

Federico J. Vázquez

Jose L. Pérez

Luis Miguel Antón Aparicio, MD

Ana Medina, MD

Joaquim Bellmunt, MD, PhD

Rafael Morales, MD

Ricardo Collado

Enrique Grande, MD

Gustavo Rubio

José Luis González, MD

Daniel Castellano, MD

Enrique González

Ovidio Fernández, MD

Maria Belén González, MD

Eduardo Pujol, MD

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.

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

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

Efficacy of cabazitaxel compared to vinflunine on terms of improved objective response rate (ORR)

Associació per a la Recerca Oncologica, Spain

Spots Global Cancer Trial Database for tccu

Every month we try and update this database with for tccu cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tccu

Every month we try and update this database with for tccu cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tccu cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.