RecruitingPhase 1NCT06269978

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

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


Sponsor

Arjun Mittra

Enrollment

24 participants

Start Date

Dec 31, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a chemotherapy treatment delivered directly into the abdomen (rather than through a vein) for colorectal cancer that has spread to the lining of the abdomen. The drugs used are oxaliplatin and fluorouracil. **You may be eligible if...** - You are 18 or older - You have colorectal cancer confirmed by biopsy that has spread to the abdominal lining (peritoneum) - You are in reasonably good physical condition (able to care for yourself) - Your blood counts and organ function are adequate **You may NOT be eligible if...** - Your cancer has spread outside the abdomen to other organs - You have already had surgery plus heated chemotherapy (HIPEC) for colorectal cancer - Your blood counts or organ function are too low Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo collection of blood and IP fluid samples

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREDiagnostic Laparoscopy

Undergo diagnostic laparoscopy

DRUGFluorouracil

Given via IP infusion

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DRUGOxaliplatin

Given via IP infusion

PROCEDURESurgical 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

View Full Details on ClinicalTrials.gov

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NCT06269978


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