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

NCT ID: NCT02115165

Last Updated: 2016-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2020-05-31

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.

Conditions

Non-seminomatous Germ-cell Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cabazitaxel

Group Type: EXPERIMENTAL

Cabazitaxel

Intervention Type: DRUG

On Day 1 of each cycle, patients will receive cabazitaxel at a dose of 25 mg/m², administered by IV route in 1 hour

Interventions

Cabazitaxel

On Day 1 of each cycle, patients will receive cabazitaxel at a dose of 25 mg/m², administered by IV route in 1 hour

Intervention Type: DRUG

Eligibility 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 </= 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

• Minimum Eligible Age: 15 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karim FIZAZI, MD-PhD

Role: STUDY_CHAIR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val de Marne, France

Site Status: RECRUITING

Countries

France

Central Contacts

Karim FIZAZI, MD-PhD

Role: CONTACT

karim.fizazi@gustaveroussy.fr

0142116264 ext. +33

Géraldine MARTINEAU, MD

Role: CONTACT

geraldine.martineau@gustaveroussy.fr

0142115607 ext. +33

Facility Contacts

Karim FIZAZI, MD-PhD

Role: primary

karim.fizazi@gustaveroussy.fr

0142116264 ext. +33

Géraldine MARTINEAU, MD

Role: backup

geraldine.martineau@gustaveroussy.fr

01422115607 ext. +33

Other Identifiers

2012/1950

Identifier Type: OTHER

Identifier Source: secondary_id

2013-000286-36

Identifier Type: -

Identifier Source: org_study_id