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

PHASE2CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

June 9, 2020

Primary Completion Date

February 25, 2023

Study Completion Date

September 5, 2024

Conditions
Gastric AdenocarcinomaGastric CancerEsophagogastric JunctionPeritoneal Carcinomatosis
Interventions
DRUG

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.

DRUG

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.

DEVICE

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.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT04034251 - Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis | Biotech Hunter | Biotech Hunter