Cetuximab With or Without Tivantinib in Treating Patients With Head and Neck Cancer That Is Recurrent, Metastatic, or Cannot Be Removed by Surgery

Summary

This randomized phase II trial studies how well cetuximab with or without tivantinib works in treating patients with head and neck cancer that has come back (recurrent), has spread to other places in the body (metastatic), or cannot be removed by surgery. Monoclonal antibodies, such as cetuximab, may interfere with the ability of tumor cells to grow and spread. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cetuximab is more effective with or without tivantinib in treating patients with head and neck cancer.

Timeline

Start

2012-08-20

Primary completion

2017-05-05

Completion

2017-05-05

Outcome

Missed primary endpoint

registry analysis (superiority test); Arm I (Cetuximab and Tivantinib) vs Arm II (Cetuximab); p = 0.99; Fisher Exact NCT01696955 ↗

Drugs

Indications