Actively Recruiting
Intraperitoneal Oxaliplatin and Fluorouracil for the Treatment of Patients With Peritoneal Metastases From Colorectal Cancer
Led by Arjun Mittra · Updated on 2026-03-10
24
Participants Needed
2
Research Sites
91 weeks
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
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.
CONDITIONS
Official 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 confirmed colorectal cancer with peritoneal metastasis only
- Primary colorectal cancer may be present or previously removed
- Prior systemic therapy for colorectal cancer allowed
- No previous cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Absolute neutrophil count (ANC) of at least 1,500 /mcL
- Platelet count of at least 100,000 /mcL
- Serum creatinine less than or equal to 1.5 times the upper limit of normal (ULN) or creatinine clearance of at least 60 mL/min if creatinine is higher
- Serum total bilirubin less than or equal to 1.5 times ULN or direct bilirubin within normal limits if total bilirubin is higher
- AST and ALT less than or equal to 2.5 times ULN
- Albumin level of at least 2.5 g/dL
- INR or prothrombin time less than or equal to 1.5 times ULN unless on anticoagulants with therapeutic levels
- Activated partial thromboplastin time (aPTT) less than or equal to 1.5 times ULN 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
- Willing to comply with study procedures
- Female participants of childbearing potential must use effective contraception during the study and for 9 months after last dose
- Negative pregnancy test required within 7 days prior to enrollment for females of childbearing potential
- Willing and able to provide informed consent
- Willing to undergo two diagnostic laparoscopies with tumor biopsy
- Willing to provide peripheral 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 on standard imaging
- Primary mucinous appendiceal tumors
- Peripheral neuropathy grade 2 or higher
- Uncontrolled illnesses including active infection, cardiac arrhythmia, active bleeding disorders, or psychiatric/social issues limiting study compliance
- Major surgery or significant injury within 3 weeks prior to starting study drug
- Minor surgery within 1 week prior to starting study drug
- Known active chronic infections such as uncontrolled HIV/AIDS or active hepatitis B or C
- Cirrhosis classified as Child-Pugh B or worse, or cirrhosis with hepatic encephalopathy or significant ascites requiring treatment
- Pregnancy or breastfeeding
- Any condition, therapy, or lab abnormality that could interfere with study results or participation, as judged by the treating physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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