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

NCT02115165 | Completed Phase 2 DMC

• 2 other identifiers: 2013-000286-362012/1950
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-seminomatous Germ-cell Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Response rate on brain metastases

  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

Study Arms (1)

Cabazitaxel

EXPERIMENTAL

Drug: Cabazitaxel

Interventions

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

Cabazitaxel

Eligibility Criteria

• Age: 15 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead
• Sanofi: collaborator

Study Sites (1)

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val de Marne, 94805, France

Location

MeSH Terms

Conditions

Nonseminomatous germ cell tumor

Interventions

cabazitaxel

Study Officials

• Karim FIZAZI, MD-PhD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 15, 2014
• Study Start: July 27, 2014
• Primary Completion: April 29, 2022
• Study Completion: April 24, 2023
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

FR (1)