Back to resultsA Prospective Study of Cabazitaxel in Patients With Non Seminomatous Germ-cell Tumors (CABA-GCT)
Primary Purpose
Non-seminomatous Germ-cell Tumors
Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Cabazitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Non-seminomatous Germ-cell Tumors
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
Sites / Locations
- Gustave Roussy Cancer Campus Grand ParisRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cabazitaxel
Arm Description
Outcomes
Primary Outcome Measures
Favorable response
To evaluate the favorable response rate of cabazitaxel treatment in patients with highly-pretreated nonseminomatous germ-cell tumors (NSGCT)
Secondary Outcome Measures
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
Progression free survival
Overall survival
Full Information
NCT ID
NCT02115165
First Posted
April 10, 2014
Last Updated
June 8, 2016
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT02115165
Brief Title
A Prospective Study of Cabazitaxel in Patients With Non Seminomatous Germ-cell Tumors
Acronym
CABA-GCT
Official Title
A Prospective Phase II Trial of Cabazitaxel in Male Patients With Chemotherapy Pre-treated Metastatic Nonseminomatous Germ-cell Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Collaborators
Sanofi
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-seminomatous Germ-cell Tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cabazitaxel
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cabazitaxel
Intervention Description
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 Measure Information:
Title
Favorable response
Description
To evaluate the favorable response rate of cabazitaxel treatment in patients with highly-pretreated nonseminomatous germ-cell tumors (NSGCT)
Time Frame
Assessed every 6 weeks from start of treatment up to 72 months
Secondary Outcome Measure Information:
Title
Response rate on brain metastases
Description
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
Time Frame
Assessed every 6 weeks after treatment start up to 72 months
Title
Progression free survival
Time Frame
Assessed every 6 weeks from treatment start to progression up to 72 months
Title
Overall survival
Time Frame
Assessed every 3 weeks after treatment start up to 72 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karim FIZAZI, MD-PhD
Phone
0142116264
Ext
+33
Email
karim.fizazi@gustaveroussy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Géraldine MARTINEAU, MD
Phone
0142115607
Ext
+33
Email
geraldine.martineau@gustaveroussy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karim FIZAZI, MD-PhD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Study Chair
Facility Information:
Facility Name
Gustave Roussy Cancer Campus Grand Paris
City
Villejuif
State/Province
Val de Marne
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim FIZAZI, MD-PhD
Phone
0142116264
Ext
+33
Email
karim.fizazi@gustaveroussy.fr
First Name & Middle Initial & Last Name & Degree
Géraldine MARTINEAU, MD
Phone
01422115607
Ext
+33
Email
geraldine.martineau@gustaveroussy.fr
First Name & Middle Initial & Last Name & Degree
Karim FIZAZI, MD-PhD
12. IPD Sharing Statement
Learn more about this trial
A Prospective Study of Cabazitaxel in Patients With Non Seminomatous Germ-cell Tumors
We'll reach out to this number within 24 hrs