Capecitabine and Oxaliplatin in Treating Patients With Locally Advanced, Unresectable, or Metastatic Stomach Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: capecitabine; oxaliplatin
Intervention MeSH terms: Capecitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent gastric cancer; stage III gastric cancer; stage IV gastric cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, 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 capecitabine together with
      oxaliplatin works in treating patients with locally advanced, unresectable, or metastatic
      stomach cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed gastric cancer

               -  Locally advanced, unresectable, or metastatic disease

          -  Measurable disease, defined as at least 1 lesion that can be accurately measured in ≥
             1 dimension as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan

          -  No known brain metastases

        PATIENT CHARACTERISTICS:

          -  ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%

          -  WBC ≥ 3,000/mm³

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Bilirubin normal

          -  AST/ALT ≤ 2.5 times upper limit of normal

          -  Creatinine ≤ 1.5 mg/dL

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during study and for 6 months after
             completion of study treatment

          -  Able to swallow

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to fluoropyrimidines or platinum chemotherapy agents

          -  No uncontrolled intercurrent illness including, but not limited to the following:

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

               -  Psychiatric illness or social situations that would preclude study compliance

        PRIOR CONCURRENT THERAPY:

          -  More than 4 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas
             or mitomycin C) and recovered

          -  At least 6 months since prior radiotherapy with capecitabine as a radioenhancer

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent chemotherapy

          -  No concurrent palliative radiotherapy

          -  No concurrent hormonal therapy except for the following:

               -  Steroids for adrenal failure

               -  Hormones for nondisease related conditions (e.g., insulin for diabetes)

               -  Intermittent use of dexamethasone as an antiemetic

          -  No other concurrent investigational agents

          -  No other concurrent anticancer agents or therapies