| Exclusion Criteria: | 1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study.
2) Women who are pregnant or breastfeeding.
3) Women with a positive pregnancy test on enrollment or prior to study therapy administration.
4) Sexually active fertile men not using effective birth control if their partners are women of child-bearing potential.
5) Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
6) A serious uncontrolled medical disorder that would impair the ability of the patient to receive protocol therapy.
7) Symptomatic or uncontrolled metastases in the brain. Patients receiving a glucocorticoid for brain metastases will be excluded, but those receiving anticonvulsants will be eligible.
8) Uncontrolled pleural effusion or ascites.
9) Peripheral neuropathy greater than grade 2, as assessed by the NCI-CTCAE, Version 3.0.
10) Any concurrent malignancy other than basal cell skin cancer, or carcinoma in situ of the cervix. Patients with a previous malignancy, but without evidence of disease for >/=3 years will be allowed to enter the trial.
11) More than one prior chemotherapy regimen for advanced disease.
12) Inadequate hematologic function defined by an absolute neutrophil count (ANC) <1,500/mm3, a platelet count <100,000/mm3, and a hemoglobin level <9 g/dL. Red blood cell transfusions are not permitted within 7 days of receiving cetuximab, docetaxel, or pemtrexed.
13) Inadequate hepatic function, defined by a total bilirubin level >1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and ALT levels >2.5 times the ULN (≥5 times the ULN if known liver metastases), and an alkaline phosphatase level >5.0 times the ULN.
14) Inadequate renal function defined by a serum creatinine level >1.5 times the ULN.
15) Prior treatment with cetuximab, or any other epidermal growth factor receptor inhibitors, including tyrosine kinase inhibitors, such as gefitinib or erlotinib. Patients must not have received prior chimerized or murine monoclonal antibody therapy. Prior treatment with other monoclonal antibodies targeting receptors other than the EGFR is permitted >30 days prior to randomization.
16) Prior treatment with docetaxel or pemetrexed therapy.
17) Inability or unwillingness to take folic acid or vitamin B12 supplementation.
18) Inability or unwillingness to interrupt nonsteroidal anti-inflammatory drugs (NSAIDs) for a 5-day period (8-day period for long-acting agents such as piroxicam). Aspirin will be permitted during the study.
19) Patients (including prisoners) who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness.
20) Employees of the investigator or study center with direct involvement in this study or other studies under the direction of the investigator or study center, as well as family members of the employees.
21) Prior treatment with an experimental drug or medical device within 30 days of randomization. |