NCT06269978

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Arjun Mittra · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Determine safety, tolerability, and maximally tolerated dose (MTD) of intraperitoneal (IP) fluorouracil (5FU)+oxaliplatin. II. Determine pharmacokinetics (PK) of IP 5FU+oxaliplatin both in blood and peritoneal fluid. SECONDARY OBJECTIVES: I. Determine tumor-cell intrinsic effects, modulation of the tumor immune microenvironment, and changes in the makeup of circulating immune cells in response to IP 5FU+oxaliplatin. II. Identify preliminary response from IP 5FU+oxaliplatin: assess the rate of conversion from unresectable to resectable (determined by peritoneal carcinomatosis index \[PCI\] decreasing to \< 20) and response rates by imaging criteria. OUTLINE: This is a dose-escalation study of 5FU and oxaliplatin followed by a dose-expansion study. Patients undergo placement of indwelling IP port for chemotherapy infusion. Patients receive oxaliplatin and 5FU over 1-2 hours via IP infusion on days 1 and 15 of each cycle. Cycles repeat every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo diagnostic laparoscopy, biopsy, computed tomography (CT)/magnetic resonance imaging (MRI), and collection of blood samples at screening and on study and undergo collection of IP fluid samples on study. After completion of study treatment, patients are followed up for 30 days. Patients with confirmed disease progression or who start a new anti-cancer therapy are followed up every 12 weeks until death, withdrawal of consent, or end of study.

Conditions

• Metastatic Colorectal Carcinoma
• Metastatic Malignant Neoplasm in the Peritoneum
• Stage IV Colorectal Cancer AJCC v8

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-12-31
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2024-02-21
• Last updated: 2026-03-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study