Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer

PRIMARY OBJECTIVES:

I. To assess overall survival from the date of diagnosis in subjects with stage IV gastric or
gastroesophageal cancer and positive cytology or carcinomatosis after cytoreduction,
gastrectomy, and hyperthermic intraperitoneal chemotherapy administration.

SECONDARY OBJECTIVES:

I. To assess the safety of cytoreduction, gastrectomy, and hyperthermic intraperitoneal
chemotherapy administration for subjects with gastric or gastroesophageal cancer and positive
cytology or carcinomatosis.

OUTLINE:

Patients undergo hyperthermic intraperitoneal chemotherapy (HIPEC) comprised of mitomycin and
cisplatin given intraperitoneally over 60 minutes during standard of care cytoreduction and
gastrectomy.

After completion of study treatment, patients are followed up within 4 weeks, and then every
6 months for 5 years.

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2

- Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal
junction

- Leukocytes >= 3,000/uL

- Absolute neutrophil count >= 1,500/uL

- Platelets >= 60,000/Ul

- Serum creatinine =< 1.5 mg/dL

- Distant metastatic disease of peritoneum may be visualized on imaging:

- Positive peritoneal cytology

- Carcinomatosis on diagnostic laparoscopy or laparotomy

- Completion of preoperative systemic chemotherapy and preoperative laparoscopic HIPEC

Exclusion Criteria:

- Distant metastatic disease not limited to peritoneum: Solid organ metastases (liver,
central nervous system, lung)

- Infections such as pneumonia or wound infections that would preclude protocol therapy

- 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

- Subjects with unstable angina or New York Heart Association grade II or greater
congestive heart failure

- Subjects deemed unable to comply with study and/or follow-up procedures

- 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