A Prospective Study of Cabazitaxel in Patients With Non Seminomatous Germ-cell Tumors

• Status: Unknown status
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Collaborator: Sanofi

Criteria

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
• Bilirubin
• 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