Irinotecan/Cisplatin, Potentially Curative Surgery With or Without Floxuridine, Followed by Capecitabine for Stomach and Gastro-esophageal Junction (GEJ) Cancers
Condition: Gastric Cancer; Gastric Adenocarcinoma; Esophageal Cancer
MeSH terms: Adenocarcinoma; Stomach Neoplasms
Intervention: Irinotecan; Cisplatin; Surgery; Floxuridine; Capecitabine
Intervention MeSH terms: Capecitabine; Irinotecan; Floxuridine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: gastric cancer; gastroesophageal junction; stomach cancer; intraperitoneal infusion; capecitabine; irinotecan; cisplatin; floxuridine

Summary:

      This study is to determine whether intraperitoneal (IP) Floxuridine is effective in the
      patients with advanced stomach or gastro-esophageal junction cancers in the treatment
      consisting of pre- and post-surgery chemotherapies.
    

Eligibility criteria:

        -  Only untreated patients with histologically documented gastric/GEJ adenocarcinoma,
             clinical American Joint Committee on Cancer (AJCC) stage grouping (11) IB-IV (Mo) by
             CT scan and laparoscopy/endoscopic ultrasound, are eligible. Excluded are patients in
             need of urgent surgery for gastro-intestinal obstruction, perforation or hemorrhage.

          -  Both men and women >= 18 years of age with Eastern Cooperative Oncology Group (ECOG)
             performance status 0-2, members of any ethnic group and minorities.

          -  Patients without another invasive malignancy, with adequately treated basal cell or
             squamous cell skin cancer, free for 5 years or more of in-situ cervix cancer or other
             in-situ cancer.

          -  Since immune deficiency increases the risk of terminal infections when aggravated by
             bone marrow suppressive therapy, patients must be without active or uncontrolled
             infection including HIV.

          -  Patients without psychiatric disorders that may interfere with their consent and/or
             with protocol follow-up.

          -  An adequate bone-marrow reserve (absolute neutrophil count >= 1,500/ mmL, thrombocytes
             >= 100,000 mmL, hemoglobin >= 9 gm/dL).

          -  Preserved liver and renal function (total serum bilirubin <2 mg/dL, SGOT/SGPT =< 3x
             the upper limit of normal, alkaline phosphatase =< 3x the upper limit of normal, blood
             urea nitrogen (BUN) =< 30 mg/dL, serum creatinine concentration <1.5 mg/dL and
             creatinine clearance >= 50 mL/min) are required. Creatinine clearance should be
             normalized for 1.73 M^2 BSA. The prothrombin time, activated partial thromboplastin
             time, and thrombin time should be within the range of normal values.

          -  Since chemotherapeutic agents to be used are known or suspected to be teratogenic or
             with other adverse effects, women must not be pregnant or breast-feeding. All females
             of childbearing potential must have a blood test or urine study within 2 weeks prior
             to registration to rule out pregnancy. All patients of reproductive age may not
             participate unless they agree to use an effective medically acceptable contraceptive
             method.

          -  Patients without diagnosed Gilbert's disease and bilirubin level >= 2.0 mg/dL, as
             these patients may have excessive CPT-11 toxicity.

          -  No prior severe reaction to fluoropyrimidine therapy or known hypersensitivity to
             5-fluorouracil. Capecitabine (Xeloda) is contraindicated in patients with severe renal
             impairment, i.e., creatinine clearance below 30 mL/min, determined by Cockcroft-Gault
             equation shown on page 15 under (i) Renal impairment. In patients with moderate renal
             impairment (creatinine clearance 30-50 mL/min), which develops during the course of
             adjuvant treatment with Capecitabine, the drug is decreased to 75% of the starting
             dose.

          -  Patients should be without any severe concurrent disease, such as cardiac condition
             not responding to medication, myocardial infarction within the last 12 months, active
             infection or uncontrolled pulmonary disease, or any other disease which in judgment of
             the investigator would make the patient inappropriate for entry into this study.

          -  Patients who signed written informed consent.