protocolSection identificationModule nctId: NCT06269978, orgStudyIdInfo id: OSU-23195, secondaryIdInfos id: NCI-2023-10497, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: R21CA282536, type: NIH, link: https://reporter.nih.gov/quickSearch/R21CA282536, briefTitle: Intraperitoneal Oxaliplatin and Fluorouracil for the Treatment of Patients With Peritoneal Metastases From Colorectal Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Arjun Mittra, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: 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., conditionsModule conditions: Metastatic Colorectal Carcinoma, conditions: Metastatic Malignant Neoplasm in the Peritoneum, conditions: Stage IV Colorectal Cancer AJCC v8, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Biopsy, interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Diagnostic Laparoscopy, interventions name: Fluorouracil, interventions name: Magnetic Resonance Imaging, interventions name: Oxaliplatin, interventions name: Surgical Procedure, outcomesModule primaryOutcomes measure: Maximum tolerated dose (MTD), primaryOutcomes measure: Incidence of adverse events, primaryOutcomes measure: Area under the curve, primaryOutcomes measure: Clearance, primaryOutcomes measure: Volume of distribution, primaryOutcomes measure: Half-life, secondaryOutcomes measure: Tumor-cell intrinsic effects in response to IP 5FU+oxaliplatin, secondaryOutcomes measure: Modulation of the tumor microenvironment in response to IP 5FU+oxaliplatin, secondaryOutcomes measure: Changes in the makeup of circulating immune cells in response to IP 5FU+oxaliplatin, secondaryOutcomes measure: Rate of conversion from unresectable to resectable, secondaryOutcomes measure: Overall response rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ohio State University Comprehensive Cancer Center, status: RECRUITING, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Arjun Mittra, MD, role: CONTACT, phone: 614-293-6529, contacts name: Arjun Mittra, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False