A Prospective Study of Cabazitaxel in Patients With Non Seminomatous Germ-cell Tumors (NCT02115165) | Clinical Trial Compass
CompletedPhase 2
A Prospective Study of Cabazitaxel in Patients With Non Seminomatous Germ-cell Tumors
France34 participantsStarted 2014-07-23
Plain-language 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.
Who can participate
Age range
15 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male patients aged 15 years or older
* Evidence of advanced NSGCT documented either by pathology or by elevated tumor markers (AFP or hCG) and a compatible clinical presentation
* Primary site located in either the testis, the retroperitoneum or the mediastinum
* Progressive disease after at least 2 lines of chemotherapy for advanced NSGCT (ie, non-stage I)
* In case of brain metastases, confirm that patients should be stable / controlled with corticosteroid/anti seizures agents
* No other progressive carcinoma within previous the 5 years, except for basal-cell carcinoma of the skin
* Life expectancy \>/= 3 months
* Adequate hematologic function :
* Hemoglobin \>/= 10.0 g/dL
* Absolute neutrophil count \>/= 1.5 x 10 \^ 9/L,
* Platelet count \>/= 100 x 10 \^ 9/L,
* Adequate organ function
* Serum creatinine \< 1.5 x ULN. If serum creatinine 1.0 - 1.5 x ULN, creatinine clearance calculated (or measured) according to CKD-EPI formula (see Appendix B) \> 60 mL/min
* AST/SGOT and ALT/SGPT \</= 1.5 x ULN
* Bilirubin \</= 1.5 x ULN
* Information delivered to patient and informed consent form signed by the patient or his legal representative
* Patient affiliated to a social security system or beneficiary of the same
Exclusion Criteria:
* Patients receiving anti cancer therapy within 4 weeks prior to enrolment
* Previous radiotherapy within 4 weeks prior to enrolment
* Serious uncontrolled concurrent medical illness
* History of severe hypersensitivity reaction…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Favorable response
Timeframe: Assessed every 6 weeks from start of treatment up to 72 months