NCT01620242

A Phase II, Open-Label, Multicenter Trial of Cabazitaxel in Patients With Recurrent or Metastatic Head and Neck Cancer After Failure Of Cisplatin, Cetuximab and Taxanes

A PHASE II, OPEN-LABEL, MULTICENTER TRIAL OF CABAZITAXEL IN PATIENTS WITH RECURRENT OR METASTATIC HEAD AND NECK CANCER AFTER FAILURE OF CISPLATIN, CETUXIMAB AND TAXANES.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center phase II study assessing whether cabazitaxel could be efficient for treatment of recurrent or metastatic head and neck cancer after failure of cisplatin, cetuximab and taxanes.

Detailed description

Patients will be treated with intravenous cabazitaxel 25 mg/m2 every 3 weeks (D1=D22) for 6 cycles. In absence of progression disease or unacceptable toxicity, the treatment could be continued until a maximum of 10 cycles. Disease response will be assessed every 6 weeks (i.e. every 2 cycles) clinically and by CT-scan. An interim analysis will be carried out after the inclusion of the first 10 eligible and assessable patients.

Conditions

• Recurrent Head and Neck Cancer
• Metastatic Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Cabazitaxel	25 mg/m2 every 3 weeks by IV administration

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-06-01
• Completion: 2014-05-27
• First posted: 2012-06-15
• Last updated: 2021-03-02

Locations

5 sites across 1 country: France