Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis

Inclusion Criteria

• •1. Patients must have histologically or cytologically confirmed gastric adenocarcinoma, including Siewert III gastroesophageal junction adenocarcinoma, confirmed by the National Cancer Institute (NCI) Laboratory of Pathology, and have provided a block or unstained slides of primary or
• •metastatic tumor tissue or newly obtained fresh biopsy of a tumor lesion in case archival tissue sample is not available.
• •2. Patients may be treatment naive or have received systemic chemotherapy prior to enrollment:
• •* Trastuzumab allowed as prior treatment for human epidermal growth factor receptor 2 (HER2)/neu over-expressing cancers as clinically indicated.
• •* Last dose of chemotherapy at least 2 weeks prior to enrollment with recovery to Grade 1 from chemotherapy-related toxicities.
• •3. Radiographic evidence of peritoneal carcinomatosis and/or sub-radiographic evidence of peritoneal carcinomatosis found at staging laparoscopy.
• •4. Age \>=18 years. Children under the age of 18 will not participate in this study as gastric cancer is rare in this population.
• •5. Eastern Cooperative Oncology Group (ECOG) performance status \<=1
• •6. Patients must have normal organ and marrow function as defined below:
• •hemoglobin \>=8.0 g/dL
• •absolute neutrophil count \>=1,000/mcL
• •platelets \>=100,000/mcL
• •total bilirubin \<=1.5 X institutional upper limit of normal
• •Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT) serum glutamic-pyruvic transaminase (SGPT) \<=2.5 X institutional upper limit of normal
• •creatinine \<1.5 mg/dl
• •OR
• •creatinine clearance \>=60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal.
• •7. Physiologically able to undergo laparoscopy and systemic chemotherapy.
• •8. Ability of subject to understand and the willingness to sign a written informed consent document.
• •9. Previous exploratory laparotomy or laparoscopy with tissue biopsy or peritoneal lavage is permitted.
• •10. 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 treatment. 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.
• •11. Patients must be co-enrolled in protocol 13C0176 (NCT01915225) and 17C0044 (NCT03027427) for sample collection.
• •12. Human immunodeficiency virus (HIV)-positive patients may be considered for this study only after consultation with a National Institute of Allergy and Infectious Diseases (NIAID) physician.