NCT02478502

Testis CAB: Cabazitaxel as Salvage Treatment for Cisplatin-resistant Germ Cell Cancer

Phase 2 Study Cabazitaxel as Salvage Treatment for Cisplatin-resistant Germ Cell

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University Hospital, Akershus · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Germ cell tumors belong to the most chemosensitive malignancies. Paclitaxel in combination with ifosfamide and cisplatin (TIP) has become a common regimen for salvage treatment of germ cell cancer. Cabazitaxel may overcome resistance to docetaxel and paclitaxel and might have clinical activity in patients with metastatic and progressive germ cell tumors.

Detailed description

Patients with metastatic germ cell cancer and relapse after two or more courses of cisplatin-based chemotherapy or after high-dose chemotherapy have a poor prognosis and no curative options. Taxanes in various combinations unfold cytotoxic effects on germ cell tumors resistant to conventional doses of cisplatin. Paclitaxel in combination with ifosfamide and cisplatin (TIP) has become a common regimen for salvage treatment of germ cell cancer. In most patients, however, resistance to paclitaxel, as evidenced by progression occurs.Cabazitaxel has been developed to overcome resistance to docetaxel and paclitaxel. It has shown efficacy in patients progressing during docetaxel therapy in a large phase III trial (TROPIC) in patients with castration-resistant prostate cancer. Furthermore, chemotherapy resistance might be less likely to develop in patients receiving cabazitaxel as compared to other taxanes.

Conditions

• Testicular Cancer

Interventions

Type	Name	Description
DRUG	cabazitaxel	cabazitaxel is given to patients with progressive testicular cancer after cisplatin-based chemotherapy

Timeline

• Start date: 2015-06-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2015-06-23
• Last updated: 2024-02-02

Locations

4 sites across 4 countries: Denmark, Italy, Norway, Sweden