Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy

Summary

This phase II trial studies how well giving temsirolimus together with cetuximab works compared to temsirolimus alone in treating patients with recurrent and/or metastatic head and neck cancer who did not respond to previous therapy. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving temsirolimus together with cetuximab is more effective than giving temsirolimus alone.

Timeline

Start

2010-11

Primary completion

2013-12

Completion

2013-12

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Arm A (Cetuximab and Temsirolimus) vs Arm B (Temsirolimus); p = 0.73; Log Rank NCT01256385 ↗

Drugs

Indications