Actively Recruiting
A Phase I Study of Intraperitoneal 5FU and Oxaliplatin for Patients With Colorectal Cancer and Peritoneal Metastases
Led by Arjun Mittra · Updated on 2026-03-10
24
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Arjun Mittra
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety, side effects, and best dose of delivering oxaliplatin and fluorouracil directly into the peritoneal cavity to treat colorectal cancer that has spread there. Both drugs are approved for colorectal cancer but using them this way is experimental. This phase I trial also looks at how the drugs affect tumor cells, the immune environment, and circulating immune cells, as well as the potential to shrink tumors enough for surgery. Participants receive chemotherapy through a port placed in the abdomen. Oxaliplatin and fluorouracil are infused into the peritoneal cavity over 1-2 hours on days 1 and 15 of each 28-day cycle. Treatment continues for up to 16 weeks unless the cancer worsens or side effects become unacceptable. The study includes diagnostic laparoscopy, biopsies, CT or MRI scans, and collection of blood and peritoneal fluid samples. During the trial, patients undergo multiple assessments including imaging and laboratory tests to monitor drug levels, tumor response, and immune changes. After treatment ends, safety is followed for 30 days. If the cancer progresses or new treatments start, patients are followed every 12 weeks until death, withdrawal, or study end. The study aims to determine the maximum tolerated dose and evaluate biological effects of the treatment over about a year.
CONDITIONS
Brief Title
Intraperitoneal Oxaliplatin and Fluorouracil for the Treatment of Patients With Peritoneal Metastases From Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Biopsy-proven colorectal cancer with spread to the peritoneal cavity only
- Primary colorectal cancer may be present or previously removed
- Prior systemic therapy for colorectal cancer is allowed
- No prior cytoreductive surgery and HIPEC for colorectal cancer
- ECOG performance status of 0 or 1
- Absolute neutrophil count at least 1,500/mcL
- Platelets at least 100,000/mcL
- Serum creatinine less than or equal to 1.5 times upper limit of normal or creatinine clearance at least 60 mL/min
- Serum total bilirubin less than or equal to 1.5 times upper limit of normal or direct bilirubin within normal limits
- AST and ALT less than or equal to 2.5 times upper limit of normal
- Albumin at least 2.5 g/dL
- INR or prothrombin time less than or equal to 1.5 times upper limit of normal unless on anticoagulants with therapeutic levels
- Activated partial thromboplastin time less than or equal to 1.5 times upper limit of normal unless on anticoagulants with therapeutic levels
- Patients on anticoagulants or antiplatelet agents allowed if these can be safely held for surgery
- Expected life expectancy of at least 6 months
- Willingness to comply with study procedures
- Female patients of childbearing potential must use contraception during and for 9 months after study
- Negative pregnancy test required for females of childbearing potential
- Ability to understand and sign informed consent
- Willingness to undergo two diagnostic laparoscopies with tumor biopsies
- Willingness to provide blood and peritoneal fluid samples for research
You will not qualify if you...
- Receiving any other investigational drugs
- Evidence of metastatic disease outside the peritoneum
- Primary mucinous appendiceal tumors
- Grade 2 or higher peripheral neuropathy
- Uncontrolled illnesses such as active infection, cardiac arrhythmia, bleeding disorders, or psychiatric/social issues limiting study compliance
- Major surgery or significant trauma within 3 weeks or minor surgery within 1 week before study drug administration
- Known active chronic infections including uncontrolled HIV/AIDS or active hepatitis B or C
- Cirrhosis with Child-Pugh B or worse or cirrhosis with hepatic encephalopathy or significant ascites
- Pregnancy or breastfeeding
- Any condition or abnormality that may interfere with study results or participation as judged by the physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo placement of an indwelling intraperitoneal (IP) port for chemotherapy infusion.
1 visit (in-person)
Duration - Up to 16 weeks
Participants receive oxaliplatin and fluorouracil (5FU) via IP infusion on days 1 and 15 of each 4-week cycle. Treatments continue for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Diagnostic laparoscopy, biopsy, CT/MRI scans, and blood and IP fluid sample collections are performed during this period.
2 visits per 4-week cycle (in-person) plus additional visits for imaging and sample collection
Duration - At least 30 days post-treatment, then every 12 weeks as needed
After completing study treatment, participants are followed for 30 days for safety monitoring. Those with disease progression or starting new anti-cancer therapy are followed every 12 weeks until death, withdrawal, or study end.
1 visit approximately 30 days after treatment and subsequent visits every 12 weeks if applicable
Trial Site Locations
Total: 2 locations
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
2
UT Southwestern/Simmons Cancer Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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