Tongue Cancer Clinical Trial
Official title:
Phase II Trial of Carboplatin/Paclitaxel and Cetuximab, Followed by Carboplatin/Paclitaxel/Cetuximab and Erlotinib, With Correlative Studies in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck.
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.
PRIMARY OBJECTIVES:
I. To determine the objective response rate when erlotinib is added to combination
carboplatin/paclitaxel/cetuximab systemic therapy in metastatic/recurrent head and neck
cancer.
SECONDARY OBJECTIVES:
I. Secondary endpoints will be toxicity, overall survival, and laboratory correlates to
determine if epidermal growth factor receptor (EGFR) signaling is more effectively inhibited
after the addition of erlotinib than it is after chemotherapy/cetuximab without erlotinib.
OUTLINE:
Patients receive cetuximab intravenously (IV) over 60 minutes, paclitaxel IV over 1 hour, and
carboplatin IV over 30 minutes on day 1. Beginning in course 2, patients also receive
erlotinib hydrochloride orally (PO) once daily (QD) on days 1-21. Courses repeat every 21
days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
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