12
Participants
Start Date
June 9, 2020
Primary Completion Date
February 25, 2023
Study Completion Date
September 5, 2024
Paclitaxel
Paclitaxel (intraperitoneal (IP) and intravenous (IV), Day 1 of each 3-week cycle: Paclitaxel IP - Intraperitoneal paclitaxel (60 mg/m\^2) will be diluted in 500 mL of 0.9% normal saline (NS), to be infused as rapidly as tolerated once per 3-week cycle on Day 1. Paclitaxel IV - Intravenous paclitaxel (80 mg/m\^2) will be administered concomitantly over 3 hours, diluted in 100 to 250 ml of 0.9% NS once per 3-week cycle on Day 1.
Capecitabine
Day 1-15 of each 3-week cycle: oral capecitabine (825 mg/m\^2) to be taken twice a day starting the evening of Day 1 of each cycle until the morning of Day 15, followed by a 7-day rest period during each 3-week cycle.
BardPort Titanium Implanted Port with Peritoneal Catheter
After peritoneal chemo infusion port is placed (Days 1-3, as dictated by clinical status), patients will begin intraperitoneal paclitaxel and intravenous paclitaxel (Day 1) followed by oral capecitabine on the evening of Day 1 to the morning of Day 15.
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH