Laparoscopic Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) for Metastatic Gastric Cancer
Condition: Gastrointestinal Cancer
MeSH terms: Gastrointestinal Neoplasms; Hyperthermia; Fever
Intervention: Mitomycin C; Cisplatin; Sodium Thiosulfate
Intervention description: Mitomycin C 30 mg delivered laparoscopically for 60 minutes.; Cisplatin 200 mg delivered laparoscopically 60 minutes, 2-8 weeks after completion of systemic chemotherapy.; Loading dose of 7.5 gm/M2 of Sodium Thiosulfate infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by continuous infusion pump over 12 hours.
Intervention MeSH terms: Sodium thiosulfate; Cisplatin; Mitomycins; Mitomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastrointestinal cancer; Hyperthermic Intraperitoneal Chemoperfusion; HIPEC; Gastric carcinomatosis; Gastroesophageal cancer; Mitomycin C; Mitomycin; Cisplatin; Platinol-AQ; Platinol; CDDP; Sodium Thiosulfate; Tinver

Summary:

      The goal of this clinical research study is to learn if hyperthermic intraperitoneal
      chemotherapy (HIPEC) will help to control the disease in patients with Stage 4 stomach or
      gastroesophageal cancer. The safety of this treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 years and above. There will be no upper age restriction.

          2. Eastern Cooperative Oncology Group (ECOG) performance status </= 2.

          3. Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal
             junction.

          4. Adequate renal, and bone marrow function: a. Leukocytes >/= 3,000/microL; b. Absolute
             neutrophil count >/= 1,500/microL; c. Platelets >/= 100,000/Ul; d. Serum creatinine
             </= 1.5 mg/dL.

          5. Hepatic function: AST (SGOT)/ALT (SGPT) </= 5 X institutional (Upper Limit of Normal)
             ULN.

          6. Distant Metastatic Disease limited to peritoneum and radiologically occult (not
             visualized on preoperative imaging to include [Computerized Tomography] CT scan,
             Ultrasound, [Magnetic Resonance Imaging] MRI, PET/CT): a. Positive peritoneal
             cytology; b. Carcinomatosis on diagnostic laparoscopy or laparotomy.

          7. Completion of preoperative systemic chemotherapy.

        Exclusion Criteria:

          1. Distant metastatic disease not limited to peritoneum: a. Solid organ metastases
             (liver, central nervous system, lung).

          2. Any distant metastatic disease visualized on preoperative imaging: a. Solid organ
             metastases; b. Clear radiologic evidence of carcinomatosis.

          3. Infections such as pneumonia or wound infections that would preclude protocol therapy.

          4. Women with a positive urine or serum pregnancy test are excluded from this study;
             women of childbearing potential (defined as those who have not undergone a
             hysterectomy or who have not been postmenopausal for at least 24 consecutive months)
             must agree to refrain from breast feeding and practice adequate contraception as
             specified in the informed consent. Adequate contraception consists of oral
             contraceptive, implantable contraceptives, injectable contraceptives, a double barrier
             method, or abstinence.

          5. Subjects with unstable angina or New York Heart Association Grade II or greater
             congestive heart failure.

          6. Subjects deemed unable to comply with study and/or follow-up procedures.

          7. Subjects with a known hypersensitivity to protocol systemic chemotherapy that was
             life-threatening, required hospitalization or prolongation of existing
             hospitalization, or resulted in persistent or significant disability or incapacity.