Non-seminomatous Germ-cell Tumors Clinical Trial
— CABA-GCTOfficial title:
A Prospective Phase II Trial of Cabazitaxel in Male Patients With Chemotherapy Pre-treated Metastatic Nonseminomatous Germ-cell Tumors
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.
| Status | Recruiting |
| Enrollment | 34 |
| Est. completion date | May 2020 |
| Est. primary completion date | May 2017 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 15 Years and older |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Gustave Roussy Cancer Campus Grand Paris | Villejuif | Val de Marne |
| Lead Sponsor | Collaborator |
|---|---|
| Gustave Roussy, Cancer Campus, Grand Paris | Sanofi |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Favorable response | To evaluate the favorable response rate of cabazitaxel treatment in patients with highly-pretreated nonseminomatous germ-cell tumors (NSGCT) | Assessed every 6 weeks from start of treatment up to 72 months | No |
| Secondary | Response rate on brain metastases | 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 |
Assessed every 6 weeks after treatment start up to 72 months | No |
| Secondary | Progression free survival | Assessed every 6 weeks from treatment start to progression up to 72 months | No | |
| Secondary | Overall survival | Assessed every 3 weeks after treatment start up to 72 months | No |