Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal Junction (GEJ) Tumors: A Phase II Study

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed adenocarcinoma of the
stomach or gastroesophageal junction

- Metastatic disease

- Patients must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded) as ≥
20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan

- No known active brain metastases

- Patients with treated brain metastases are eligible if stable off steroids for
at least 30 days

PATIENT CHARACTERISTICS:

- ECOG performance status ≤ 2 (Karnofsky performance status ≥ 60%)

- Life expectancy ≥ 3 months

- WBC ≥ 3,000/μL

- Absolute neutrophil count ≥ 1,500/μL

- Platelets ≥ 100,000/μL

- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)

- AST or ALT ≤ 2.5 x ULN (< 5 x ULN if known liver metastases)

- Creatinine clearance ≤ 1.5 x ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 21 days after
completion of study treatment

- No history of allergic reactions to fluorouracil or oxaliplatin

- No concurrent uncontrolled illness including, but not limited to, ongoing or active
infection or psychiatric illness/social situations that would limit compliance with
study requirements

PRIOR CONCURRENT THERAPY:

- No prior therapy for metastatic disease

- Prior neoadjuvant or adjuvant therapy is allowed if the disease-free interval
has been longer than 6 months

- No other concurrent chemotherapy

- No concurrent combination anti-retroviral therapy for HIV-positive patients

- No concurrent routine prophylaxis with filgrastim (G-CSF)

- No other concurrent antineoplastic agents, including chemotherapy, radiation therapy,
or biologic agents