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

 Gastric cancer is a common and serious cancer. Standard treatment is chemotherapy drugs.
 Researchers want to see if a new treatment helps. It is surgical removal of the cancer and
 heated chemotherapy delivered to the abdominal cavity called HIPEC.

 Objective:

 To test if surgical removal of tumors plus heated intraperitoneal chemotherapy can improve
 survival in people with gastric cancers.

 Eligibility:

 People ages 18 and older with gastric cancer who can have most tumors surgically removed

 Design:

 Participants will be screened with:

 -  Medical history

 -  Physical exam

 -  Blood, urine, and heart tests

 -  Scans

 -  Tissue sample from previous surgery

 -  Endoscopy with biopsy: A tube with a camera goes through the mouth and into the stomach.
 It and takes a sample of stomach tissue. Participants might may get medicine to make
 them drowsy.

 -  Laparoscopy: Small cuts are made in the abdomen. A thin tube with a light and camera is
 inserted into the abdomen. Participants sleep through the procedure.

 Participants will stay in the hospital. They will have:

 -  Surgery to remove as many tumors as possible.

 -  HIPEC for 60 minutes: Two thin tubes are put into the abdomen. Two chemotherapy drugs
 are given through one tube. They are drained out through another at a temperature a few
 degrees above normal body temperature. Another drug is given in a vein.

 Recovery for 7-21 days: Participants will have tubes in their stomach and bladder and IVs for
 a few days. They will get pain medicine, IV fluids, antibiotics, and blood transfusions as
 needed.

 Participants will have visits every few months for 3 years, then one a year. Visits include
 physical exam, blood tests, and scans. They also include dietary assessment and questions.
Background:

 -  An estimated 24,590 cases of gastric adenocarcinoma are diagnosed annually in the U.S.

 -  The peritoneal surface is a site of metastasis found often at time of diagnosis and is a
 common (40%) site of recurrence.

 -  Laparoscopy with peritoneal lavage and cytopathologic analysis is a staging modality
 that can identify a subset of patients with microscopic peritoneal metastasis prior to
 consideration for definitive surgical therapy

 -  Intraperitoneal chemotherapy has been employed in advanced gastric cancers and as an
 adjuvant with an associated improvement in survival in systematic reviews

 Objectives:

 - Determine the overall survival in patients with cytology-positive gastric cancer treated
 with HIPEC and gastrectomy

 Eligibility:

 -  Histologically confirmed adenocarcinoma of the stomach

 -  Cytopathologic evidence of peritoneal carcinomatosis

 -  Medically fit for systemic chemotherapy, HIPEC and gastrectomy

 Design:

 - Single arm, phase II study of HIPEC and gastrectomy
-  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.