Conditions: Head and Neck Cancer Carcinoma, Squamous
Keywords: cancer head and neck cancer squamous cell cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 16
Healthy volunteers: no

Brief summary:
A study of Oxaliplatin and Docetaxel followed by Cetuximab for head and neck cancer patients to determine their effect on the control and reduction of tumor size

Detailed description:
This is a non-randomized, open-label, phase II study to assess the effects of oxaliplatin and docetaxel followed by epidermal factor-antibody (EGFR-AB) cetuximab on patients with previously treated recurrent /metastatic squamous cell carcinoma of the head and neck. Head and neck tissue will also be tested to determine if the protein Epidermal Growth Factor Receptor is present in the cancer cells.

Arms:
arm 1: Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.

Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.

Interventions: intervention 1: Oxaliplatin intervention 2: Docetaxel intervention 3: Cetuximab
Intervention descriptions: intervention 1: 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles intervention 2: 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles intervention 3: 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks

Protocol document: