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

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris (Other)
Overall Status
Unknown status
CT.gov ID
NCT02115165
Collaborator
Sanofi (Industry)
34
Enrollment
1
Location
1
Arm
72
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 1, 2014
Anticipated Primary Completion Date :
May 1, 2017
Anticipated Study Completion Date :
May 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Favorable response [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 [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 [Assessed every 6 weeks from treatment start to progression up to 72 months]

  3. Overall survival [Assessed every 3 weeks after treatment start up to 72 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gustave Roussy Cancer Campus Grand Paris Villejuif Val de Marne France 94805

Sponsors and Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris
  • Sanofi

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT02115165
Other Study ID Numbers:
  • 2013-000286-36
  • 2012/1950
First Posted:
Apr 15, 2014
Last Update Posted:
Jun 9, 2016
Last Verified:
Jun 1, 2016
Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Testicular Neoplasms

Study Results

No Results Posted as of Jun 9, 2016