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
• •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