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 ]
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