Laparoscopic Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) for Metastatic Gastric Cancer

HIPEC Treatment:

If you are found to be eligible to take part in this study, on the day of HIPEC treatment,
you will receive heated mitomycin-C and cisplatin as a liquid that is injected through 3 to 4
small incisions in your abdomen for about 1 hour. This will be done as a surgical procedure,
and you will be under general anesthesia. The chemotherapy will then be flushed out of your
abdomen and collected, and the treatment area inside your abdomen will be washed. Also during
the HIPEC procedure, fluid will be collected and checked for cancer cells. As is standard of
care, any lesions that are found during treatment may also be biopsied at this time, if the
study doctor thinks it is necessary. You may receive up to 5 HIPEC treatments on this study.

You will also receive sodium thiosulfate by vein over about 20 minutes to protect the
kidneys.

You will remain in the hospital for 3-7 days after treatment.

While you are in the hospital after surgery:

- Blood (about 2-3 tablespoons) may be drawn for routine tests, if the study doctor thinks
it is necessary.

Study Visits:

One (1) time between Weeks 2-6:

- You will have a physical exam.

- Blood (about 2-3 tablespoons) will be drawn for routine tests.

Gastrectomy Surgery:

If your doctor thinks it is needed, you will have a standard of care surgery. You will
receive a separate consent form which explains the surgery and its risks.

On or before 8 weeks after your surgery:

- You will have a physical exam.

- Blood (about 2-3 tablespoons) will be drawn for routine tests.

Follow-Up Visits:

You will have routine clinic visits every 6 months from the date of your last surgery. You
will be asked about any other cancer treatments you may be receiving. If you stopped the
study early, the study doctor may ask you to return to the office for extra CT scans, PET
scan, or MRIs during the follow-up period.

You will have a CT scan, PET scan, or MRI of your chest, abdomen, and pelvis every 6 months
for 5 years after surgery to check the status of the disease.

Length of Study Participation:

You will be on study for about 5 years after your last surgery. You will be taken off study
early if the disease gets worse, if intolerable side effects occur, or if you are unable to
follow study directions.

Your participation on the study will be over after the follow-up visits.

This is an investigational study. The chemotherapy and surgery are standard treatment for
stomach and gastroesophageal cancer. It is investigational to give the chemotherapy by HIPEC.

Up to 30 participants will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Age 18 years and above. There will be no upper age restriction.

2. Eastern Cooperative Oncology Group (ECOG) performance status
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

5. Hepatic function: AST (SGOT)/ALT (SGPT) 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.