A Prospective Study of Cabazitaxel in Patients With Non Seminomatous Germ-cell Tumors (CABA-GCT)
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|ClinicalTrials.gov Identifier: NCT02115165|
Recruitment Status : Unknown
Verified June 2016 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was: Recruiting
First Posted : April 15, 2014
Last Update Posted : June 9, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-seminomatous Germ-cell Tumors||Drug: Cabazitaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Phase II Trial of Cabazitaxel in Male Patients With Chemotherapy Pre-treated Metastatic Nonseminomatous Germ-cell Tumors|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||May 2020|
On Day 1 of each cycle, patients will receive cabazitaxel at a dose of 25 mg/m², administered by IV route in 1 hour
- 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)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115165
|Contact: Karim FIZAZI, MD-PhD||0142116264 ext +firstname.lastname@example.org|
|Contact: Géraldine MARTINEAU, MD||0142115607 ext +email@example.com|
|Gustave Roussy Cancer Campus Grand Paris||Recruiting|
|Villejuif, Val de Marne, France, 94805|
|Contact: Karim FIZAZI, MD-PhD 0142116264 ext +33 firstname.lastname@example.org|
|Contact: Géraldine MARTINEAU, MD 01422115607 ext +33 email@example.com|
|Principal Investigator: Karim FIZAZI, MD-PhD|
|Study Chair:||Karim FIZAZI, MD-PhD||Gustave Roussy, Cancer Campus, Grand Paris|