Clinical Trial: A Prospective Study of Cabazitaxel in Patients With Non Seminomatous Germ-cell Tumors

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective Phase II Trial of Cabazitaxel in Male Patients With Chemotherapy Pre-treated Metastatic Nonseminomatous Germ-cell Tumors

Brief Summary:

Cabazitaxel is a new generation taxane with a high capacity for blood-brain barrier crossing and limited peripheral neuro-toxicity, two major potential advantages in patients with advanced NSGCTs.

Cabazitaxel has a broader in vitro spectrum of activity than docetaxel. Taxanes have demonstrated activity in pre-treated GCTs and are now part of standard treatment, but cabazitaxel has not yet been tested in patients with NSGCT.


Detailed Summary:
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Current Primary Outcome: Favorable response [ Time Frame: Assessed every 6 weeks from start of treatment up to 72 months ]

To evaluate the favorable response rate of cabazitaxel treatment in patients with highly-pretreated nonseminomatous germ-cell tumors (NSGCT)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Response rate on brain metastases [ Time Frame: Assessed every 6 weeks after treatment start up to 72 months ]

    MRI of the brain every 6 weeks only in case of brain metastases detected at baseline and for all patients at the end of the study.

    Evaluation will be made using RECIST V1.1

  • Progression free survival [ Time Frame: Assessed every 6 weeks from treatment start to progression up to 72 months ]
  • Overall survival [ Time Frame: Assessed every 3 weeks after treatment start up to 72 months ]


Original Secondary Outcome: Same as current

Information By: Gustave Roussy, Cancer Campus, Grand Paris

Dates:
Date Received: April 10, 2014
Date Started: May 2014
Date Completion: May 2020
Last Updated: June 8, 2016
Last Verified: June 2016