OncoMatch/Clinical Trials/NCT06269978
Intraperitoneal Oxaliplatin and Fluorouracil for the Treatment of Patients With Peritoneal Metastases From Colorectal Cancer
Is NCT06269978 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Fluorouracil and Oxaliplatin for metastatic colorectal carcinoma.
Treatment: Fluorouracil · Oxaliplatin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Tumor Agnostic
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: cytoreductive surgery and hyperthermic intraperitoneal chemotherapy
Lab requirements
Blood counts
ANC ≥ 1,500 /mcL; Platelets ≥ 100,000 / mcL; INR or PT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants; 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
Kidney function
Serum creatinine ≤ 1.5 x ULN OR measured or calculated creatinine clearance ≥ 60 mL/min for patient with creatinine levels > 1.5 x institutional ULN (GFR can also be used in place of creatinine or creatinine clearance)
Liver function
Serum total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patient with total bilirubin levels > 1.5 ULN; AST and ALT ≤ 2.5 x ULN; Albumin >= 2.5 g/dL
ANC ≥ 1,500 /mcL; Platelets ≥ 100,000 / mcL; Serum creatinine ≤ 1.5 x ULN OR measured or calculated creatinine clearance ≥ 60 mL/min...Serum total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN...AST and ALT ≤ 2.5 x ULN; Albumin >= 2.5 g/dL; INR or PT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy...aPTT ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
- UT Southwestern/Simmons Cancer Center · Dallas, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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