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

Primary Objectives:

To assess overall survival from the date of diagnosis in subjects with stage IV gastric or gastroesophageal cancer and positive cytology or carcinomatosis after perioperative intraperitoneal paclitaxel and gastrectomy.

Secondary Objectives:

To assess the safety of gastrectomy in subjects with stage IV gastric or gastroesophageal cancer and positive cytology or carcinomatosis undergoing treatment with perioperative intraperitoneal paclitaxel.

Inclusion criteria

• 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.
• ECOG performance status ≤ 2 (Karnofsky ≥60%). Appendices 1 and 2.
• Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction.
• Adequate renal, and bone marrow function:

• Leukocytes >= 3,000/uL
• Absolute neutrophil count >= 1,500/uL
• Platelets >= 60,000/Ul
• Serum creatinine <= 1.6 mg/dL
• Distant Metastatic Disease of peritoneum:

• Positive peritoneal cytology, or
• Carcinomatosis on diagnostic laparoscopy or laparotomy.
• Completion of preoperative systemic cytotoxic chemotherapy. Targeted therapy, such as HER2 directed therapy, and immunotherapy, such as PD-1 inhibitors, may be continued.
• English and non-English speaking patients are eligible.

Exclusion criteria

• Distant metastatic disease not limited to the peritoneum such as solid organ metastases to the liver, central nervous system, or 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 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).
• Subjects with unstable angina or New York Heart Association Grade II or greater congestive heart failure.
• Subjects, such as those with cognitive impairment, 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.
• Previous surgery that would preclude safe cytoreduction and intraperitoneal port placement.