| | Requirement |
| 1 | Histologically or cytologically confirmed advanced or metastatic gastric or gastroesophageal adenocarcinoma. |
| 2 | Age at least 18 years old. |
| 3 | SWOG PS < / = 2. |
| 4 | AGC = / >1.5; platelets = / >100,000. |
| 5 | Bilirubin < / = 1.5 x uln; SGOT/SGPT < / = 2.5 x uln (or < / = 5 x uln in case of liver metastases); alk phos < / = 2.5 x uln (or < / = 5 x uln in case of liver metastases, or < / = 10 x uln in case of bone disease). |
| 6 | Estimated CrCl at least 30 ml/min; creatinine < / = 1.5 x uln. |
| 7 | Life expectancy at least 3 months. |
| 8 | At least 1 measurable lesion (RECIST criteria) which has not been irradiated, i.e., newly arising lesions in previously irradiated areas are accepted. Ascites, pleural effusion, and bone metastases are not considered measurable. |
| 9 | Tumor biopsy (paraffin-embedded or fresh frozen) must be available at time of diagnosis and/or prior to study entry. |
| 10 | Must agree to have 20 cc blood sample drawn in addition to routine labs with each cycle of chemotherapy. |
| 11 | Willing to participate and able to comply with protocol for the duration of study. |
| 12 | Signed informed consent (including HIPAA authorization). |
| 1 | Prior chemotherapy for metastatic or unresectable disease. Prior adjuvant therapy allowed, as long as it was completed prior to 6 months of study initiation. |
| 2 | Serious, uncontrolled, or concurrent infections or illnesses. |
| 3 | Any prior oxaliplatin treatment. |
| 4 | Prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to 5-FU, or known DPD deficiency. |
| 5 | Prior unanticipated severe reaction or hypersensitivity to platinum-based compounds. |
| 6 | Completion of previous chemotherapy regimen <4 weeks prior to start of study treatment (within 6 weeks of study treatment for mitomycin-C and nitrosoureas), or with related toxicities unresolved prior to start of study treatment. |
| 7 | Pregnant or lactating women. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to initiation of chemotherapy. Women and men of childbearing potential must agree to use effective form of birth control while on study and to continue this contraceptive method for 30 days from date of last study drug administration. Post-menopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. |
| 8 | Treatment for other carcinomas within the last 5 years, except cured non-melanoma skin and treated in-situ cervical cancer. |
| 9 | Participation in any investigational drug study within 4 weeks preceding start of study treatment. |
| 10 | Clinically significant cardiac disease (e.g., CHF, symptomatic CAD, and cardiac arrhythmias not well controlled with medication), MI within the last 12 months, uncontrolled HTN, unstable angina, or cardiomyopathy with decreased ejection fraction. |
| 11 | History of clinically significant interstitial lung disease and/or pulmonary fibrosis. |
| 12 | History of persistent neurosensory disorder, including but not limited, to peripheral neuropathy. |
| 13 | Evidence of CNS metastases (unless CNS metastases have been stable for >3 months) or history of uncontrolled seizures, CNS disorders, or psychiatric disability judged by investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake. Presence of other serious uncontrolled medical conditions that investigator feels might compromise study participation. |
| 14 | Major surgery within 4 weeks of start of study treatment, without complete recovery. |
| 15 | Lack of physical integrity of upper GI tract or malabsorption syndrome. |
| 16 | Known existing uncontrolled coagulopathy. |
| 17 | Prior therapy which specifically and directly targets the EGFR pathway. |
| 18 | Prior severe infusion reaction to a monoclonal antibody. |
