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RECRUITING
NCT06269978
PHASE1

Intraperitoneal Oxaliplatin and Fluorouracil for the Treatment of Patients With Peritoneal Metastases From Colorectal Cancer

Sponsor: Arjun Mittra

View on ClinicalTrials.gov

Summary

This phase I trial tests the safety, side effects, and best dose of intraperitoneal oxaliplatin and fluorouracil in treating patients with colorectal cancer that has spread to the peritoneal cavity (peritoneal metastasis). Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Fluorouracil stops cells from making DNA and it may kill cancer cells. Both oxaliplatin and fluorouracil are approved by the Food and Drug Administration to treat patients with colorectal cancer, however administration of these drugs directly into the area between the muscles and organs in the abdomen (intraperitoneal) for the treatment of peritoneal metastases is experimental. Giving oxaliplatin and fluorouracil directly into the peritoneal space may be a safe and effective way of treating patients with peritoneal metastases from colorectal cancer.

Official title: A Phase I Study of Intraperitoneal 5FU+Oxaliplatin in Patients With Colorectal Cancer With Isolated Peritoneal Metastasis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2024-12-31

Completion Date

2026-09-30

Last Updated

2026-03-10

Healthy Volunteers

No

Interventions

PROCEDURE

Biopsy

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo collection of blood and IP fluid samples

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Diagnostic Laparoscopy

Undergo diagnostic laparoscopy

DRUG

Fluorouracil

Given via IP infusion

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Oxaliplatin

Given via IP infusion

PROCEDURE

Surgical Procedure

Undergo placement of indwelling IP port

Locations (2)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

UT Southwestern/Simmons Cancer Center

Dallas, Texas, United States