Docetaxel+Oxali+/-Cetux Met Gastric/GEJ

This is an interventional treatment trial for Gastric Cancer Adenocarcinoma Metastatic focused on measuring metastatic gastric or adenocarcinoma of the GE junction Read More

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