Oxaliplatin and mFOLFIRI Regimen for the Treatment of Unresectable Peritoneal Carcinomatosis from Colorectal or Appendiceal Cancer

Inclusion Criteria

• Histopathologically or cytologically confirmed unresectable colon, rectal or appendiceal adenocarcinoma with synchronous or metachronous (defined as occurring > 6 months after initial diagnosis) peritoneal dissemination of disease (stage IV peritoneal-based disease only)
• Patient has active, measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and assessed by either abdominal computed tomography/magnetic resonance imaging (CT/MRI)
• Patients must be willing and able as assessed the treating investigator to undergo placement of an IP catheter and a Port-A Cath, if not already present
• Patients must have known satisfactory cardiopulmonary function as assessed by the treating investigator
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Absolute neutrophil count (ANC) > 1200/mm^3
• Platelet count > 100,000/mm^3
• Total bilirubin =< 1.5 X institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional ULN
• International normalized ratio (INR) =< 1.5
• Patients who are therapeutically anticoagulated and whose antithrombotic treatment can be withheld for operation are eligible
• Blood urea nitrogen (BUN) within normal limits
• Serum creatinine within normal limits
• Estimated glomerular filtration rate (eGFR) >= 50 mL/min/1.73 m^2 or creatinine clearance >= 50 mL/min by Cockcroft-Gault
• Negative serum or urine pregnancy test at screening for women of childbearing potential
• Highly effective contraception for both male and female subjects throughout the study and for at least 30 days after last study treatment administration if the risk of conception exists
• Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5 from toxicities related to any prior treatments, unless adverse events (AEs) are clinically non-significant and/or stable on supportive therapy
• Willing to return for follow-up
• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

Exclusion Criteria

• Sensory neuropathy > grade 1 from prior therapy
• Known low or absent dipyrimidine dehydrogenase (DPD) activity
• Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
• Patients with metastases outside the peritoneal cavity
• The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: * Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class 2B or better * Other clinically significant disorders that would preclude safe study participation
• Known human immunodeficiency virus (HIV) infection with a detectable viral load within 6 months of the anticipated start of treatment. * Note: Patients on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial
• Known chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection with a detectable viral load * Note: Patients with an undetectable HBV viral load on appropriate suppressive therapy are eligible. Patients with an undetectable HCV viral load on appropriate treatment are eligible
• Live vaccinations, except flu and coronavirus disease (COVID), within 4 weeks of cycle one day one and while on trial
• Known prior severe hypersensitivity to platinum compounds, any of the investigational medication or any component in its formulations (National Cancer Institute [NCI] CTCAE v 5.0 grade >= 3)
• Subjects taking prohibited medications. A washout period of prohibited medications for a period of at least 5 half-lives or 4 weeks, whichever is shorter, should occur prior to the start of treatment