Intraperitoneal Oxaliplatin in Combo w IV mFOLFIRI for Peritoneal Carcinomatosis From Colorectal & Appendiceal Cancer

• Status: Terminated
• Trial end date: 2021-05-14
• Target enrollment: 0
• Participant gender: All

Summary

This study is a prospective, multi-center, open-label phase I trial designed to determine the maximun tolerated dose of IP oxaliplatin when given in combination with mFOLFIRI.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Treatments: Oxaliplatin

Criteria

Inclusion Criteria:

• Male or female subject aged ≥ 18 years.

• 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 RECIST 1.1 and assessed by either abdominal 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.

• ECOG Performance Status ≤ 2.

• Adequate organ function as defined as:

• Hematologic:

• Absolute neutrophil count (ANC) > 1200/mm3

• Platelet count > 100,000/mm3

• Hepatic:

• Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)

• AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN

• Coagulation:

• International normalized ratio (INR) ≤ 1.5

• Patients who are therapeutically anticoagulated and whose antithrombotic treatment can be withheld for operation are eligible.

• Renal:

• BUN and serum creatinine within normal limits.

• eGFR ≥50 mL/min/1.73m2 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 CTCAE v.5 from toxicities related to any prior treatments, unless AE(s) 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 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 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 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 (NCI CTCAE v5.0 Grade ≥ 3).

• Subjects taking prohibited medications as described in Section 6.4.2. 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.