Inclusion Criteria

Criteria:

- Histologically confirmed squamous cell carcinoma of the head and neck that is
metastatic or recurrent

- No prior systemic therapy for metastatic/recurrent disease

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Prior chemotherapy in the induction, organ preservation or adjuvant setting is
permitted if it was completed more than 4 months prior to enrollment on the current
study

- Prior cetuximab is permitted if it was given for no more than 9 doses in combination
with radiation therapy or chemoradiation therapy for initial treatment of locally
advanced disease

- No prior erlotinib, gefitinib or lapatinib therapy is permitted; nor is prior
exposure to any investigational EGFR or panErbB reversible or irreversible inhibitor
or any prior panitumumab or investigational EGFR-directed monoclonal antibody
permitted

- Hemoglobin > 9.0 G/dl

- Absolute neutrophil count (ANC) > 1500 cells/mcl

- Creatinine (Cr) < 1.8

- Total bilirubin =< the institution's upper limit of normal (ULN), aspartate
aminotransferase (AST) and alanine transaminase (ALT) < 2 X ULN

- No chronic active viral infection

- No other malignancy within 3 years

- No chronic diarrheal condition

- Females should not be pregnant or breast feeding because chemotherapy may be harmful
to the fetus or the nursing infant; also, the effects of erlotinib and cetuximab on
the developing human fetus are unknown

- All females of childbearing potential must have a blood test or urine study within 2
weeks prior to randomization to rule out pregnancy

- Women of childbearing potential and sexually active males must use an accepted and
effective method of contraception while on treatment and for three months after the
completion of treatment

- Patients must have measurable disease based on Response Evaluation Criteria In Solid
Tumors (RECIST); baseline measurements and evaluations must be obtained within < 4
weeks of randomization; all areas of disease should be recorded and mapped out in
order to assess response and uniformity of response to therapy; disease in previously
irradiated sites is considered measurable if there has been unequivocal disease
progression or biopsy-proven residual carcinoma following radiation therapy;
persistent disease without clear-cut progression after radiotherapy can be considered
measurable if biopsy-proven at least 8 weeks after completion of radiation therapy

- Patients with a prior history of squamous cell or basal carcinoma of the skin or in
situ cervical cancer must have been curatively treated; patients with a history of
other prior malignancy must have been treated with curative intent and must have
remained disease-free for 3 years post diagnosis

- No current peripheral neuropathy > grade 2 at time of randomization

- Patients must not have any co-existing condition that would preclude full compliance
with the study

- Human immunodeficiency virus (HIV) positive patients receiving combination
anti-retroviral therapy are excluded from the study because of possible
pharmacokinetic interactions with erlotinib

- Patients must have no history of allergic reaction to murine proteins

- Ability to understand and the willingness to sign a written informed consent

- Patients must not be receiving other investigational anti-cancer therapy

- Patients with brain metastases are not eligible

- Both men and women and members of all races and ethnic groups are eligible for this
trial