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Intraperitoneal Oxaliplatin and Fluorouracil for Colorectal Cancer with Peritoneal Metastases

This study is testing the safety, side effects, and best dose of two chemotherapy drugs, oxaliplatin and fluorouracil, when given directly into the abdomen (intraperitoneal) for colorectal cancer that has spread to the lining of the abdomen (peritoneal metastases). Oxaliplatin and fluorouracil are approved for colorectal cancer, but giving them this way is experimental. The study aims to find the highest safe dose and how the drugs move through your body. It also looks at how the treatment affects cancer cells and the immune system, and if it can shrink tumors. You may be able to join if you are at least 18 years old and have colorectal cancer that has spread only to the peritoneum. The study plans to enroll 24 participants, but its current recruitment status is unclear.

Study design
This is a Phase 1 study, meaning it focuses on safety and dosage. It is an interventional study, but the specific design (e.g., single-arm, blinded) is not detailed.
What's involved
You would have an indwelling port placed for chemotherapy. You would receive oxaliplatin and fluorouracil infusions every two weeks for up to 16 weeks. You would also undergo diagnostic laparoscopy, biopsies, CT scans, and blood and fluid sample collections.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for 30 days after completing the study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06269978

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

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Arjun Mittra
~9 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:BiopsyBiospecimen CollectionComputed TomographyDiagnostic LaparoscopyFluorouracilMagnetic Resonance Imaging

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose (MTD)
Measured over Up to 1 year
+5 more outcomes measured

Conditions

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

Explore related trials

Colorectal Carcinoma

Where it's being run

2 sites across 2 states
Ohio1
Texas1

Study leadership

  • Arjun Mittra, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age \>= 18 years
Biopsy proven colorectal cancer with peritoneal metastasis. Patients with extraperitoneal metastases will not be eligible. Patients with involvement of intra-abdominal lymph nodes may be eligible at the discretion of the treating physician
Primary colorectal cancer may either be left in place or have been resected prior to study enrollment
Patients are allowed to have received prior colorectal cancer-directed systemic therapy.
Not previously undergone cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at the time of enrollment
Absolute neutrophil count (ANC) ≥ 1,500 /mcL
Platelets ≥ 100,000 / mcL
Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥ 60 mL/min for patient with creatinine levels \> 1.5 x institutional ULN (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\])
Creatinine clearance should be calculated per institutional standard
Serum total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patient with total bilirubin levels \> 1.5 ULN
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
Both values must be in the specified range
Albumin \>= 2.5 g/dL
International normalized ratio (INR) or prothrombin time (PT) =\< 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Patients on anticoagulation or antiplatelet agents may be enrolled at the discretion of the treating physician, provided these can be safely held as needed for surgical procedures
Anticipated life expectancy of ≥ 6 months
Willing to comply with study procedures
Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study and at least 9 months after the last dose of study medication
For female patients of childbearing potential, a negative pregnancy test is required at or within 7 days prior to enrollment
Be willing and able to understand and sign the written informed consent document
Be willing to undergo two diagnostic laparoscopies with tumor biopsy tissue. Patients must consent to on-treatment biopsies prior to initiation of clinical trial
Be willing to provide peripheral blood and peritoneal samples for correlative studies

Exclusion

Patients who are receiving any other investigational drugs
Evidence of metastatic disease other than peritoneum based on standard of care (SOC) imaging
Patients with primary mucinous appendiceal tumors will not be eligible. These tumors often produce mucin, which may affect the penetration of IP chemotherapy. Patients with non-mucinous appendiceal adenocarcinomas will be eligible.
Patients with \>= grade 2 peripheral neuropathy
Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, cardiac arrhythmia, active bleeding diatheses, and psychiatric illness/social situations that would limit compliance with study requirements
Major surgical procedure or significant traumatic injury less than 3 weeks or those who receive minor surgical procedures within 1 week from first dose of study drug administration
Known active chronic infections - uncontrolled human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), known active (i.e., with detectable polymerase chain reaction \[PCR\]) hepatitis B or C
Cirrhosis (Child-Pugh B or worse) or cirrhosis with history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
Pregnancy or breastfeeding
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating physician

What this trial measures

  • Maximum tolerated dose (MTD)Up to 1 year

    MTD will be determined based on isotonic regression. Specifically, the MTD will be selected as the dose for which the isotonic estimate of the toxicity rate is closest to the targeted dose limiting toxicities via Bayesian optimal interval software.

  • Incidence of adverse eventsUp to 30 days after completion of study treatment

    Adverse events (AEs) will be classified and attributed using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 and will be summarized within and across dose levels using descriptive statistics. The overall number and percentage of patients experiencing AEs and toxicities will be summarized and reported as across all event types. All patients who have received at least one dose of the therapeutic agents will be evaluable for toxicity and tolerability.

  • Area under the curveAt the end of Cycle 1 (each cycle is 28 days)

    Will be computed using non-compartmental and compartmental methods. Will use graphical analyses as well as repeated measure models (linear or nonlinear mixed models, generalized estimating equations) to assess the pharmacokinetic markers in relation to clinical treatment outcomes, recognizing some inherent limitations due to sample size.

  • ClearanceAt the end of Cycle 1 (each cycle is 28 days)

    Will be computed using non-compartmental and compartmental methods. Will use graphical analyses as well as repeated measure models (linear or nonlinear mixed models, generalized estimating equations) to assess the pharmacokinetic markers in relation to clinical treatment outcomes, recognizing some inherent limitations due to sample size.

  • Volume of distributionAt the end of Cycle 1 (each cycle is 28 days)

    Will be computed using non-compartmental and compartmental methods. Will use graphical analyses as well as repeated measure models (linear or nonlinear mixed models, generalized estimating equations) to assess the pharmacokinetic markers in relation to clinical treatment outcomes, recognizing some inherent limitations due to sample size.

  • Half-lifeAt the end of Cycle 1 (each cycle is 28 days)

    Will be computed using non-compartmental and compartmental methods. Will use graphical analyses as well as repeated measure models (linear or nonlinear mixed models, generalized estimating equations) to assess the pharmacokinetic markers in relation to clinical treatment outcomes, recognizing some inherent limitations due to sample size.