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

Stopped early · Phase 2

Conditions studied: Gastric Adenocarcinoma, Gastric Cancer, Esophagogastric Junction, Peritoneal Carcinomatosis

In brief

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.

Key facts

Study ID

NCT04034251

Run by

National Cancer Institute (NCI)

People needed

12

Starts

2020-06-09

Expected to finish

2024-09-05

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients who are receiving any other investigational agents.
• Previous cytoreductive surgery or intraperitoneal chemotherapy.
• Disseminated extra-peritoneal or solid organ metastases:
• Excludes greater omentum and ovarian metastases.
• Radiographic signs or clinical symptoms consistent with malignant bowel obstruction.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Paclitaxel or Capecitabine or other agents used in study.
• Previous treatment with paclitaxel or nab-paclitaxel resulting in progression of disease.
• Existing peripheral neuropathy, Grade 3 or greater.
• Past medical history of dihydropyrimidine dehydrogenase deficiency.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded because paclitaxel and capecitabine can cause fetal harm when administered to pregnant women. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with paclitaxel and capecitabine, breastfeeding should be discontinued if the mother is treated with paclitaxel and capecitabine.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.