A Prospective Study of Cabazitaxel in Patients With Non Seminomatous Germ-cell Tumors (CABA-GCT)

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.

Study Overview

• Status: Unknown
• Conditions: Non-seminomatous Germ-cell Tumors
• Intervention / Treatment: Drug: Cabazitaxel

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Karim FIZAZI, MD-PhD; Phone Number: +33 0142116264; Email: karim.fizazi@gustaveroussy.fr
• Study Contact Backup: Name: Géraldine MARTINEAU, MD; Phone Number: +33 0142115607; Email: geraldine.martineau@gustaveroussy.fr

Study Locations

• France
  • Val de Marne
    • Villejuif, Val de Marne, France, 94805
      • Recruiting
      • Gustave Roussy Cancer Campus Grand Paris
      • Contact: Karim FIZAZI, MD-PhD; Phone Number: +33 0142116264; Email: karim.fizazi@gustaveroussy.fr
      • Contact: Géraldine MARTINEAU, MD; Phone Number: +33 01422115607; Email: geraldine.martineau@gustaveroussy.fr
      • Principal Investigator: Karim FIZAZI, MD-PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cabazitaxel	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Collaborators: Sanofi
• Investigators: Study Chair: Karim FIZAZI, MD-PhD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: April 10, 2014
• First Submitted That Met QC Criteria: April 14, 2014
• First Posted (Estimate): April 15, 2014

Study Record Updates

• Last Update Posted (Estimate): June 9, 2016
• Last Update Submitted That Met QC Criteria: June 8, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Endocrine System Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Testicular Diseases; Neoplasms, Germ Cell and Embryonal; Testicular Neoplasms
• Other Study ID Numbers: 2013-000286-36; 2012/1950 (Other Identifier: CSET number)