Phase II Trial of Docetaxel Plus Oxaliplatin (DOCOX) With Cetuximab in Patients With Metastatic Gastric and/or Gastroesophageal Junction Adenocarcinoma

Inclusion Criteria:

- Patient has histologically confirmed Stage IV adenocarcinoma of the GEJ/stomach

Note: Adjuvant radiation plus treatment with 5-FU and leucovorin is permitted, but not
required.

- Patients must have measurable disease

- Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2

- Patient is greater than 18 years of age

- If present, any pre-existing (current) peripheral neuropathy must be ≤ Grade 1

- Patient's laboratory values must fall within the limits set forth in section 4.2 of
the protocol

- Patient has a negative serum pregnancy test within 7 days prior to registration
(female patients of childbearing potential)

- If fertile, patient (male or female) has agreed to use an acceptable method of birth
control to avoid pregnancy for the duration of the study and for a 2 month period
thereafter

- Patient (or guardian) has signed a Patient Informed Consent Form

- Patient (or guardian) has signed a Patient Authorization Form

Exclusion Criteria:

- Patient has any metastatic disease other than that defined in section 4.2 (criterion
#1)

- Patient has had prior treatment that included anything other than adjuvant radiation
plus treatment with 5-FU and leucovorin. Prior treatment must have been completed >
6 months prior to registration in current study. No other prior regimens are
allowed.

Note: Adjuvant radiation plus treatment with 5-FU and leucovorin is permitted, but not
required.

- If present, any peripheral neuropathy is > Grade 1

- Patient has a known hypersensitivity to Taxotere (or any drug formulated with
Polysorbate-80), or Eloxatin

- Has had a prior severe infusion reaction (Grade 4) to a monoclonal antibody

- Has received prior therapy, at any time, which specifically and directly targets the
EGFR pathway

- Patient is receiving concurrent immunotherapy or any other concurrent treatment for
their cancer

- Has had prior stem cell or bone marrow transplant or any organ transplant with the
exception of corneal transplant or cadaver bone graft

- Has a significant history of uncontrolled cardiac disease; ie, uncontrolled
hypertension, unstable angina, recent myocardial infarction (within prior 6 months),
uncontrolled congestive heart failure, or cardiomyopathy with decreased ejection
fraction (LVEF<50%)

- Has evidence of CNS involvement (CNS imaging is not required for study enrollment
unless clinically suspected CNS disease is present.)

- Patient has a serious uncontrolled intercurrent medical or psychiatric illness,
including serious infection

- Patient is known to be HIV positive or have a history of hepatitis B or C

- Patient has a history of other malignancy within the last 5 years (except for
squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix , or
superficial transitional cell carcinoma of the bladder), which could affect the
diagnosis or assessment of current condition.

- Patient is a pregnant or lactating woman