NCT04034251

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

A Phase II Study of Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background: Three-fourths of people diagnosed with gastric cancer will die from it. Researchers want to see if giving cancer drugs in a new way can help people live longer and delay the time it takes for the cancer to grow. Objective: To find a better way to treat advanced stomach cancer. Eligibility: People ages 18 and older with stomach cancer that has spread throughout their belly. Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests Scans Cancer sample: If they do not have one, they will have a biopsy. Tests of performance of normal activities Dietary assessment Participants will have a laparoscopy. Small cuts are made into their abdomen. A thin camera with a light is inserted. Small instruments are used to take biopsies. This will be repeated during the study to monitor the cancer. During the first laparoscopy, a port with a catheter attached will be put into the abdomen. Participants may also have an endoscopy: A thin tube with a camera is inserted through the mouth and into the stomach. The tube collects samples to monitor the cancer. Participants will get paclitaxel every 3 weeks through the abdominal port and through a small plastic tube in an arm vein. They will also take capecitabine by mouth twice daily for the first 15 days of a 21-day cycle. After participants finish 3 cycles, they will have scans to see how they are doing. They may get another course of therapy. Participants will have visits every 3 weeks during treatment. Then they will have follow-up visits for 5 years. Then they will keep in touch with researchers for the rest of their life.

Detailed description

Background: * An estimated 28,000 cases of gastric adenocarcinoma are diagnosed annually in the United States (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 intraperitoneal progression free survival (iPFS) 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 age greater 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 undergo staging laparoscopy and placement of peritoneal access port. * Intraperitoneal paclitaxel (60 mg/m\^2 weekly), intravenous paclitaxel (80 mg/m\^2 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.

Conditions

• Gastric Adenocarcinoma
• Gastric Cancer
• Esophagogastric Junction
• Peritoneal Carcinomatosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-09
• Primary completion: 2023-02-25
• Completion: 2024-09-05
• First posted: 2019-07-26
• Last updated: 2025-02-03
• Results posted: 2023-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study