At a glance
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A Phase II Trial of Induction Chemotherapy Followed by Cetuximab (Erbitux) With Low Dose vs. Standard Dose IMRT in Patients With HPV-Associated Resectable Squamous Cell Carcinoma of the Oropharynx
In Brief
A Phase 2 clinical trial evaluating cetuximab, intensity-modulated radiation therapy (IMRT), and 2 other interventions for Head and Neck Cancer and Precancerous Condition. Completed, enrolled 90 participants across 121 sites.
Detailed Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, 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. Radiation therapy uses high energy x-rays to kill tumor cells. Giving paclitaxel, cisplatin, and cetuximab together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying paclitaxel, cisplatin, and cetuximab to see how well they work when followed by cetuximab and two different doses of intensity-modulated radiation therapy in treating patients with HPV-associated stage III or stage IV cancer of the oropharynx that can be removed by surgery.
Study Details
Timeline
Interventions
Given IV
Patients undergo low-dose OR standard dose IMRT based on their clinical response to induction therapy
Given IV, 90 mg/m\^2 on days 1, 8 and 15
Given IV, 75 mg/m\^2 on day 1