S0425 Oxaliplatin, Capecitabine, and RT in Treating Patients W/Stomach Cancer That Can Be Removed By Surgery
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: capecitabine; oxaliplatin; conventional surgery; radiation therapy
Intervention description: 850 mg/m2/dose PO q 12 hours Days 1-14 and 22-35. 650 mg/m2/dose PO q 12 hours Days 43-77.; 130 mg/m2 by 2-hour infusion Days 1 and 22; Distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy; Beginning Day 43, patients will be treated 5 days/week at 180 cGy/day times 25 fractions to a total dose of 4,500 cGy.
Intervention MeSH terms: Capecitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the stomach; stage I gastric cancer; stage II gastric cancer; stage III gastric cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy
      together with radiation therapy before surgery may make the tumor smaller and reduce the
      amount of normal tissue that needs to be removed.

      PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine
      together with radiation therapy works in treating patients with stomach cancer that can be
      removed by surgery.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed primary adenocarcinoma of the stomach, meeting the following
             criteria:

               -  Newly diagnosed disease amenable to curative resection

               -  Stage IB-III (T2-4)

          -  Measurable or nonmeasurable disease

          -  Enlarged lymph nodes outside of radiation fields must have preoperative biopsies

               -  No positive lymph nodes outside of radiation fields

          -  No distant metastasis

          -  No gastroesophageal junction tumors

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-1

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  WBC ≥ 3,000/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Creatinine ≤ 1.5 times upper limit of normal

          -  Albumin ≥ 3 g/dL

          -  Bilirubin normal

          -  No evidence of ischemic heart disease by EKG

          -  No coronary artery disease requiring active medical treatment

          -  No symptoms of angina

          -  No history of myocardial infarction

          -  No deep vein thrombosis within the past 12 months

          -  No pre-existing peripheral neuropathy

          -  No active pneumonia or inflammatory lung infiltrate

          -  No prior malignancy except for adequately treated basal cell or squamous cell skin
             cancer, in situ cervical cancer, or other cancer for which the patient has been
             disease free for ≥ 5 years

          -  No clinically significant comorbid medical conditions that would prevent delivery of
             chemotherapy, radiotherapy, or the performance of surgery

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

          -  At least 4 weeks since prior and no concurrent sorivudine or brivudine

          -  No prior therapy for this malignancy, including chemotherapy, surgery, immunotherapy,
             or radiotherapy

          -  No prior coronary angioplasty or stenting

          -  No concurrent 2-dimensional or intensity-modulated radiotherapy