Conditions: Cancer
Keywords: head neck
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 39
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if the addition of a unique targeted agent called Cetuximab (also known as "C225" and "Erbitux") can increase the effectiveness of standard treatment with chemotherapy and radiation.

Detailed description:
This research study involves the use of a combination of two chemotherapies, cisplatin and docetaxel, which have been known to shrink head and neck cancers and are a commonly used treatment for this type of cancer. This combination will then be followed by radiation and more chemotherapy.

The purpose of this study is to see whether this combination of chemotherapy and radiation, with the addition of Cetuximab, can improve control of disease and collect information on what side effects this combination therapy may have. In addition, biologic factors (markers) will be studied that may help to predict and treat head and neck cancer patients in the future.

Arms:
arm 1: Induction chemotherapy consists of 3 cycles of cisplatin 75 mg/m\^2, on day 1, docetaxel 75 mg/m\^2, on day 1, and cetuximab weekly days 1,8,15, repeated every 21 days (cetuximab dose is 400 mg/m\^2 on day 1 and 250 mg/m\^2 on subsequent weekly treatments). After 3 cycles of induction, patients receive standard radiation 70 Gy/200 cGy/daily, 5 days/week with concurrent weekly cisplatin 30 mg/m\^2 and cetuximab 250 mg/m\^2. After completing radiation therapy, patients receive cetuximab weekly as maintenance therapy for 6 months (see section 5 for detailed treatment plan and dose modifications)

Interventions: intervention 1: Docetaxel intervention 2: Cisplatin intervention 3: Cetuximab intervention 4: Radiation Therapy
Intervention descriptions: intervention 1: Docetaxel 75 mg/m\^2 IV over 1 hour, day 1 intervention 2: Cisplatin 75 mg/m\^2 IV over 1-2 hours, day 1, 1 hour following completion of cetuximab infusion. intervention 3: Cetuximab dose will be 250 mg/m\^2 IV over 60 minutes weekly on ALL subsequent administrations (days 8 and 15 of cycle 1 and days 1,8,15 of cycles 2 and 3). intervention 4: Photon energies of 1.25 to 6 MV and/or appropriate electron energies for boosting the nodes are allowed. Photon energies\>6 MV may be utilized when appropriate to boost target localized centrally.

Protocol document: