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Completed

NCT Number: NCT02115165

A Prospective Study of Cabazitaxel in Patients With Non Seminomatous 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.

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Key information

Conditions

Non-seminomatous Germ-cell Tumors Nonseminomatous germ cell tumor

Age range

15 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val de Marne, 94805, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cabazitaxel

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Collaborators

  • Sanofi

Registry information

Official study title

A Prospective Phase II Trial of Cabazitaxel in Male Patients With Chemotherapy Pre-treated Metastatic Nonseminomatous Germ-cell Tumors

Acronym: CABA-GCT

Important dates

Study start
2014
Primary completion
2022
Study completion
2023
First posted
Apr 15, 2014
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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