NCT02115165CompletedPhase 2
A Prospective Phase II Trial of Cabazitaxel in Male Patients With Chemotherapy Pre-treated Metastatic Nonseminomatous Germ-cell Tumors
Gustave Roussy, Cancer Campus, Grand Paris1 site in 1 country34 target enrollmentStarted: July 23, 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Favorable response
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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 (>/= grade 3) to polysorbate 80 containing drugs or to other taxanes
- •Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (see Appendix A). A one week wash-out period is necessary for patients who are already on these treatments.
- •Patient with reproductive potential not implementing accepted and effective method of contraception for up to 6 months after the last dose of cabazitaxel.
- •Active Grade >/= 3 peripheral neuropathy
- •Patients who have had a major surgery within 4 last weeks prior enrolment
- •Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension. History of congestive heart failure (NYHA III or IV) or myocardial infarction within last 6 months is also not allowed
Arms & Interventions
Cabazitaxel
Experimental
Intervention: Cabazitaxel (Drug)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Response rate on brain metastases(Assessed every 6 weeks after treatment start up to 72 months)
- Progression free survival(Assessed every 6 weeks from treatment start to progression up to 72 months)
- Overall survival(Assessed every 3 weeks after treatment start up to 72 months)
Investigators
Study Sites (1)
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