Combination Chemotherapy as First-Line Therapy in Treating Patients With Stage IV Gastric Cancer That Cannot Be Removed By Surgery
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Docetaxel; Floxuridine; Leucovorin; Oxaliplatin
Intervention MeSH terms: Leucovorin; Docetaxel; Oxaliplatin; Floxuridine; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent gastric cancer; stage IV gastric cancer; adenocarcinoma of the stomach

Summary:

      RATIONALE: Drugs used in chemotherapy, such as floxuridine, leucovorin, oxaliplatin, and
      docetaxel, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)
      may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well combination chemotherapy works as
      first-line therapy in treating patients with stage IV gastric cancer that cannot be removed
      by surgery.
    

Eligibility criteria:

        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