Carboplatin, Paclitaxel, Cetuximab, and Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Head and Neck Squamous Cell Cancer

Summary

This phase II trial is studying how well giving carboplatin, paclitaxel, cetuximab, and erlotinib hydrochloride together works in treating patients with metastatic or recurrent squamous cell head and neck cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with cetuximab and erlotinib hydrochloride may kill more tumor cells.

Timeline

Start

2011-02-16

Primary completion

2015-04-07

Completion

2017-10-03

Outcome

Met primary endpoint

paper With an ORR of 58.3%, the study met its primary endpoint. PMID 40166973 ↗

Publications

• Bhatia A, Mehra R, Bauman J, Khan SA, Wei W, Neumeister V, Sandoval-Schaefer T, Alpaugh RK, Lango M, Rimm DL, Ridge JA, Burtness B. Phase II Trial of Chemotherapy, Cetuximab, and Erlotinib in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck. Head Neck. 2025 Sep;47(9):2373-2382. doi: 10.1002/hed.28152. Epub 2025 Apr 1.

Drugs

Indications