• Overall clinical response rate (complete response and partial response) [ Designated as safety issue: No ]
  
• Efficacy [ Designated as safety issue: No ]
  

• Safety [ Designated as safety issue: Yes ]
  
• Overall survival [ Designated as safety issue: No ]
  
• Time to progression [ Designated as safety issue: No ]
  
• 6-month survival [ Designated as safety issue: No ]
  
• 1-year survival [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• Determine the overall response rate in patients with unresectable stage IV gastric adenocarcinoma treated with floxuridine, leucovorin calcium, oxaliplatin, and docetaxel as first-line treatment.

Secondary

• Determine the feasibility of this regimen in managing patients with unresectable stage IV gastric adenocarcinoma who have not received prior chemotherapy for metastatic disease.
• Determine disease-free survival of patients treated with this regimen.
• Evaluate overall survival of patients treated with this regimen.
• Assess the safety and toxicity of this regimen in these patients.

OUTLINE: Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and docetaxel IV over 30 minutes, floxuridine IV over 24 hours, and leucovorin calcium IV over 24 hours on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed gastric adenocarcinoma meeting the following criteria:

  • Stage IV disease OR stage III disease that was re-staged as metastatic disease at time of surgery
  • Unresectable disease
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• No CNS metastases

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
• Absolute neutrophil count ≥ 1,500/mm^3
• Hemoglobin ≥ 8.0 g/dL
• Platelet count ≥ 100,000/mm^3
• Bilirubin normal
• Creatinine ≤ 1.5 mg/dL

• Alkaline phosphatase (AP), AST, and ALT must meet 1 of the following criteria:

  • AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
  • AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN
  • AP ≤ 5 times ULN AND AST and ALT normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after completion of study therapy
• No peripheral neuropathy > grade 1
• No history of severe hypersensitivity reaction to platinum agents (e.g., cisplatin or carboplatin), fluoropyrimidines, or drugs formulated with polysorbate 80
• No concurrent serious illness that would preclude study treatment or compliance
• No active infections requiring intravenous antibiotic therapy
• No other malignancy within the past 5 years except for cervical carcinoma in situ, breast ductal carcinoma in situ, colonic polyp, or squamous cell or basal cell carcinoma of the skin
• No clinically significant uncontrolled cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias) or myocardial infarction within the past 12 months

PRIOR CONCURRENT THERAPY:

• No prior radiotherapy for metastatic gastric carcinoma

• No prior chemotherapy for metastatic gastric carcinoma

  • Prior neoadjuvant or adjuvant chemotherapy and/or radiotherapy allowed if completed therapy at least 12 months before study enrollment

    • Chemotherapy may have included taxane, platinum, or fluoropyrimidine-based regimen
• At least 2 months since prior surgery and recovered
• No other concurrent investigational agents
• No other concurrent anticancer agents or therapies