Fluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer

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