Fluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: fluorouracil; leucovorin calcium; oxaliplatin; gene expression analysis; polymorphism analysis; protein expression analysis; pharmacological study
Intervention description: Given through a vein over 5 minutes and then continuously over 46 hours on days 1 and 15.; through a vein over 2 hours on days 1 and 15.; 500 ml D5W through a vein over 2 hours on days 1 and 15.; Blood collection; Blood collection; Blood collection; Blood collection
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Calcium; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the stomach; stage IV gastric cancer; recurrent gastric cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin,
      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 giving fluorouracil together with
      oxaliplatin and leucovorin works in treating patients with metastatic stomach cancer or
      gastroesophageal junction cancer.
    

Eligibility criteria:

        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