Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology

INCLUSION CRITERIA:
Patients must have histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction (Siewert I-III) adenocarcinoma confirmed by the Laboratory of Pathology, NCI
Must have received systemic chemotherapy, minimum 3 months or maximum 6 months, prior to enrollment
Systemic therapy should consist of at least fluoropyrimidine-based and/or platinum based chemotherapy
Trastuzumab may be added for HER2-neu over-expressing cancers as clinically indicated
Last dose of chemotherapy within 8 weeks of enrollment with recovery to Grade 1 from chemotherapy-related toxicities
Documentation of chemotherapy administration must be obtained
Subradiographic and/or cytopathologic evidence of peritoneal carcinomatosis found at staging laparoscopy.
Documentation of cytopathologic diagnosis of malignant peritoneal cytology in the absence of disseminated peritoneal disease must be obtained. If cytologic analysis reveals atypical cells of undetermined significance, a repeat lavage with cytopathologic analysis will be performed and must demonstrate evidence of malignancy.
Limited peritoneal involvement found at staging laparoscopy or on final pathology that is deemed completely resectable is permitted
Age >18 years.
ECOG performance status <2
Patients must have normal organ and marrow function as defined below:

hemoglobin > 8.0 g/dL

absolute neutrophil count greater than or equal to 1,000/mcL

platelets greater than or equal to100,000/mcL

total bilirubin within normal institutional limits

AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal

creatinine < 1.5 mg/dl

eGFR (creatinine clearance) greater than or equal to 60 mL/min/1.73 m2.

Physiologically able to undergo HIPEC and gastrectomy
No history of malignancy within 2 years of enrollment except for basal cell carcinoma of the skin, squamous cell skin cancer or carcinoma in situ of the cervix.
Ability of subject to understand and the willingness to sign a written informed consent document
Previous exploratory laparotomy or laparoscopy with tissue biopsy or peritoneal lavage is permitted.
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Subjects must agree to co-enrollment on the tissue collection protocol 13C0176, Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors .

EXCLUSION CRITERIA:

Patients who are receiving any investigational agents
Disseminated extra-peritoneal or solid organ metastases

Includes carcinomatosis associated with clinically or radiographically evident ascites (greater than 500cc)

--Excludes greater omentum and ovarian metastases

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study because HIPEC and gastrectomy have not been studied in pregnant women and has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with HIPEC and gastrectomy, breastfeeding should be discontinued if the mother is treated on this study.
HIV-positive patients may be considered for this study only after consultation with a NIAID physician.