At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed squamous cell or undifferentiated carcinoma of the head and neck (excluding nasopharynx, paranasal sinus, and parotid gland)
- ✓Unresectable locally advanced or regional stage IV disease with no distant metastases
- ✓Demonstrable primary tumor site and measurable disease
- ✓ECOG performance status 0-1
- ✕Prior radiotherapy to the head and neck region
- ✕Prior chemotherapy
- ✕Prior excisional surgery of head and neck tumor
- ✕Prior drugs targeting epidermal growth factor receptor pathway or chimerized/murine monoclonal antibodies
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of C225 (Erbitux or Cetuximab) in Combination With Cisplatin and Definitive Radiation in Unresectable Stage IV Squamous Cell Carcinoma of the Head and Neck
In Brief
A Phase 2 clinical trial evaluating cetuximab C225, cisplatin, and 1 other intervention for Head and Neck Cancer. Completed, enrolled 69 participants.
Detailed Summary
RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Cetuximab may make the tumor cells more sensitive to radiation therapy and chemotherapy. Giving monoclonal antibody therapy together with chemoradiotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with locally advanced or regional stage IV head and neck cancer that cannot be removed by surgery.
Study Details
Timeline
Interventions
400 mg/m\^2 IV over 120 minutes on Day 1, 250 mg/m\^2 IV over 60 minutes on Day 8, then weekly
75 mg/m\^2 IV over 30-60 minutes starting day 15 every 3 weeks \* 3 (Days 1, 22, and 43 of radiation therapy (RT))
RT 70 Gy / 35 starting Day 15, 200cGy / d \* 7 weeks (35 fractions)