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

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Background: An estimated 28,000 cases of gastric adenocarcinoma are diagnosed annually in the U.S. Peritoneal metastasis is a common finding at diagnosis, making curative surgical resection possible in an estimated 25% of patients. Systemic chemotherapy is the recommended treatment for patients with...

Background: An estimated 28,000 cases of gastric adenocarcinoma are diagnosed annually in the U.S. Peritoneal metastasis is a common finding at diagnosis, making curative surgical resection possible in an estimated 25% of patients. Systemic chemotherapy is the recommended treatment for patients with metastatic gastric cancer to the peritoneal cavity, however selective use of cytoreductive surgery and intraperitoneal chemotherapy has been associated with improved overall survival. Multiple chemotherapeutic agents and delivery systems have been described for intraperitoneal therapy, but no standard regimen exists. Objective: -Determine the progression free survival (PFS) in patients with peritoneal metastases from gastric cancer after repeated intraperitoneal chemotherapeutic infusion (IPC) and systemic paclitaxel administration with concomitant capecitabine therapy. Eligibility: Histologically confirmed adenocarcinoma of the stomach. Radiographic evidence of peritoneal carcinomatosis and/or sub-radiographic evidence of peritoneal carcinomatosis found at staging laparoscopy. Medically fit for systemic chemotherapy and intraperitoneal chemotherapy. Men and women agegreater than or equal to 18 years. Design: Phase II, nonrandomized, open label study. Patients will enroll in two cohorts: those with prior systemic chemotherapy and those who are treatment naive. Patients will undergo staging laparoscopy and placement of peritoneal access port. Intraperitoneal paclitaxel (60 mg/m^2 weekly), intravenous paclitaxel (80 mg/m2 weekly), and capecitabine (825 mg/m^2 twice daily for 14 days of each cycle) for 12 weeks. Treatment response will be assessed with imaging and laparoscopy. It is expected that 16-20 patients per year for total 4 years will be enrolled. The accrual ceiling is set at 74 patients.

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