Docetaxel+Oxali+/-Cetux Met Gastric/GEJ
Condition: Gastric Cancer Adenocarcinoma Metastatic
MeSH terms: Adenocarcinoma
Intervention: Docetaxel; cetuximab; oxaliplatin
Intervention description: Taxotere 60 mg/m2 as an intravenous (IV) infusion over 1 hour; ERBITUX 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes.; Eloxatin 130 mg/m2 IV over 2 hours
Intervention MeSH terms: Docetaxel; Oxaliplatin; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic gastric or adenocarcinoma of the GE junction

Summary:

      The purpose of this research study is to find out what effects (good and bad) docetaxel,
      oxaliplatin, and cetuximab have on gastric or GEJ cancer.
    

Eligibility criteria:

        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