Irinotecan and Cisplatin in Treating Patients Who Are Undergoing Surgery For Locally Advanced Cancer of the Stomach or Gastroesophageal Junction
Condition: Gastric Adenocarcinoma; Stage II Gastric Cancer; Stage III Gastric Cancer; Stage IV Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Cisplatin; Computed Tomography; Fludeoxyglucose F-18; Fluorothymidine F-18; Irinotecan Hydrochloride; Positron Emission Tomography; Therapeutic Conventional Surgery
Intervention description: Given IV; Undergo FDG and FLT PET/CT; Undergo FDG-PET/CT; Undergo FLT-PET/CT; Given IV; Undergo FDG and FLT PET/CT; Undergo radical subtotal or total gastrectomy with lymph node dissection
Intervention MeSH terms: Deoxyglucose; Alovudine; Cisplatin; Irinotecan; Camptothecin; Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well giving irinotecan together with cisplatin works in
      treating patients who are undergoing surgical resection for locally advanced cancer of the
      stomach or gastroesophageal junction. Drugs used in chemotherapy, such as irinotecan and
      cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or
      die. Combining more than one chemotherapy drug and giving them before surgery may shrink the
      tumor so that it can be removed during surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients must have microscopically confirmed adenocarcinoma of the stomach or
             gastroesophageal (GE) junction with material reviewed by the Department of Pathology
             of the participating Institution; tumors involving the GE junction must have the bulk
             of their disease in the stomach; tumors of the distal esophagus that extend less than
             2cm into the stomach are ineligible for this study; using the Siewert's classification
             for the GE junction, tumors designated as Types II and III are indeed considered
             eligible for this clinical trial

          -  All patients must have localized cancer potentially curable by surgery; the tumor
             stage should be Tany N+ M0 or T3-T4 Nany M0, by staging that includes a computed
             tomography (CT) scan and either laparoscopy-assisted pancreatobiliary (LAP) or
             endoscopic ultrasound (EUS); patients with T1-2N0M0 tumors, confirmed by LAP ("good
             risk") are ineligible; any sites of suspected M1 disease by these criteria must be
             proven to be M0 prior to entrance into a neoadjuvant trial

          -  Patients must have a Karnofsky Performance Status >= 60% (Eastern Cooperative Oncology
             Group [ECOG] =< 2) and be able to tolerate the proposed surgical procedure and
             chemotherapy regimen

          -  Patients may not have received prior chemotherapy or radiation for this disease

          -  Absolute neutrophil count (ANC) >= 1,500 cells/mm^3

          -  Platelets >= 100,000/mm^3

          -  Serum creatinine =< 1.5 mg/dL

          -  Total serum bilirubin =< 1.5 mg/dL

          -  Patients must have signed informed consent indicating that they are aware of the
             investigational nature of the study and that participation is voluntary

          -  No clinically significant auditory impairment

          -  No clinically significant peripheral neuropathy

          -  New York Heart Association (NYHA) class I-II

          -  Patients must not have a prior history of cancer within the last five years except for
             non-melanoma skin cancer, non-metastatic prostate cancer or carcinoma in situ of the
             uterine cervix

        Exclusion Criteria:

          -  Any metastatic disease

          -  NYHA Class III or IV heart disease; history of active angina or myocardial infarction
             within 6 months; history of significant ventricular arrhythmia requiring medication
             with antiarrhythmics or a history of a clinically significant conduction system
             abnormality

          -  Pregnant or lactating women are ineligible; fertile men and women, unless using
             effective contraception, are ineligible; a pregnancy test will be performed on
             sexually active women of childbearing potential prior to entry into the study;
             treatment may not begin until the results of the pregnancy test are ascertained

          -  Serious intercurrent infections, or nonmalignant medical illnesses that are
             uncontrolled or whose control may be jeopardized by the complications of this therapy

          -  Grade 2 or greater pre-existing peripheral neuropathy

          -  Psychiatric disorders rendering patients incapable of complying with the requirements
             of the protocol

          -  Any concurrent active malignancy other than non-melanoma skin cancers, non-metastatic
             prostate cancer or carcinoma-in-situ of the uterine cervix; patients with previous
             malignancies but without evidence of disease for > 5 years will be allowed to enter
             the trial

          -  Clinically significant hearing loss