A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology

Eligibility Criteria

• 1. Age 18 years and above. There will be no upper age restriction. Because no dosing or adverse event data are currently available on the use of intraperitoneal paclitaxel in patients \<18 years of age, children are excluded from this study.
• 2. ECOG performance status ≤ 2 (Karnofsky ≥60%). Appendices 1 and 2.
• 3. Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction.
• 4. Adequate renal, and bone marrow function:
• 1. Leukocytes \>= 3,000/uL
• 2. Absolute neutrophil count \>= 1,500/uL
• 3. Platelets \>= 60,000/Ul
• 4. Serum creatinine \<= 1.6 mg/dL
• 5. Distant Metastatic Disease of peritoneum:
• 1. Positive peritoneal cytology, or
• 2. Carcinomatosis on diagnostic laparoscopy or laparotomy.
• 6. Completion of preoperative systemic cytotoxic chemotherapy. Targeted therapy, such as HER2 directed therapy, and immunotherapy, such as PD-1 inhibitors, may be continued.
• 7. English and non-English speaking patients are eligible.
• 1. Distant metastatic disease not limited to the peritoneum such as solid organ metastases to the liver, central nervous system, or lung.
• 2. Infections such as pneumonia or wound infections that would preclude protocol therapy.
• 3. Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who are not postmenopausal defined as no menses in greater than or equal to 12 months, have not had a hysterectomy or bilateral salpingo-oophorectomy, do not have ovarian failure, or have not had a surgical sterilization procedure) 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. Men with reproductive potential must agree to an appropriate method of birth control, including abstinence or double barrier method (diaphragm plus condom).
• 4. Subjects with unstable angina or New York Heart Association Grade II or greater congestive heart failure.
• 5. Subjects, such as those with cognitive impairment, deemed unable to comply with study and/or follow-up procedures.
• 6. 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.
• 7. Previous surgery that would preclude safe cytoreduction and intraperitoneal port placement.