A Randomized, Double-Blind, Phase 2 Safety Study of Cetuximab, Using ImClone Versus Boehringer Ingelheim Manufacturing Processes, in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First-Line Treatment of Patients With Locoregionally Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria:

- Head and neck cancer that was confirmed by tissue or cell biopsy

- Disease not suitable for local therapy

- Measurable or evaluable disease

- Karnofsky performance status(KPS)score of at least 70

- Organs are functioning well (bone marrow reserve, liver and kidney)

- Life expectancy of at least 12 weeks

- Signed informed consent document

Exclusion Criteria:

- Receiving another investigational medication within the last 30 days

- Prior chemotherapy, except if given as part of a multimodal treatment for locally
advanced head and neck cancer that was completed more than 4 months prior to study
entry.

- Nasopharyngeal carcinoma

- Previous treatment with monoclonal antibody therapy or other signal transduction
inhibitors or EGFR targeting therapy except for prior cetuximab treatment given as
part of a multimodal treatment for locally advanced head and neck cancer that was
completed more than 4 months prior to study entry.

- Uncontrolled high blood pressure

- Heart disease or had a heart attack within the last year

- Currently have an infection that requires for you to take an IV antibiotic

- Currently receiving other therapies for your cancer, such as chemotherapy, radiation
therapy, immunotherapy, and hormonal therapy

- Medical or psychological condition that would not permit the patient to complete the
study or sign informed consent

- Known drug abuse (with the exception of alcohol abuse)

- Known allergic reaction against any of the components of the study treatment

- Second primary malignancy that is clinically detectable at the time of consideration
for study enrollment

- Have had another type of cancer within the last 2 years

- You are currently pregnant or breastfeeding

- You are considering becoming pregnant or fathering a child