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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02115165
Recruitment Status : Unknown
Verified June 2016 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
First Posted : April 15, 2014
Last Update Posted : June 9, 2016
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

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.

Condition or disease Intervention/treatment Phase
Non-seminomatous Germ-cell Tumors Drug: Cabazitaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Phase II Trial of Cabazitaxel in Male Patients With Chemotherapy Pre-treated Metastatic Nonseminomatous Germ-cell Tumors
Study Start Date : May 2014
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Cabazitaxel

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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Response rate on brain metastases [ Time Frame: Assessed every 6 weeks after treatment start up to 72 months ]

    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

  2. Progression free survival [ Time Frame: Assessed every 6 weeks from treatment start to progression up to 72 months ]
  3. Overall survival [ Time Frame: Assessed every 3 weeks after treatment start up to 72 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02115165

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Contact: Karim FIZAZI, MD-PhD 0142116264 ext +33
Contact: Géraldine MARTINEAU, MD 0142115607 ext +33

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Gustave Roussy Cancer Campus Grand Paris Recruiting
Villejuif, Val de Marne, France, 94805
Contact: Karim FIZAZI, MD-PhD    0142116264 ext +33   
Contact: Géraldine MARTINEAU, MD    01422115607 ext +33   
Principal Investigator: Karim FIZAZI, MD-PhD         
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
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Study Chair: Karim FIZAZI, MD-PhD Gustave Roussy, Cancer Campus, Grand Paris
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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris Identifier: NCT02115165    
Other Study ID Numbers: 2013-000286-36
2012/1950 ( Other Identifier: CSET number )
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Testicular Neoplasms
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders