Trial of Intraperitoneal (IP) Oxaliplatin in Combination With Intravenous FOLFIRI

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase I dose escalation study to determine how much chemotherapy can be safely administered into the abdomen while experiencing the fewest possible side effects.

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

Details

• Lead Sponsor: University of Massachusetts, Worcester
• Treatments: Oxaliplatin

Criteria

Inclusion Criteria:

• Must be 18 years of age or older and capable of providing informed consent indicating awareness of the investigational nature of this trial, in keeping with institutional policy

• Must consent to participate in the trial and have signed an approved informed consent form conforming to institutional policy

• Must have histopathologically or cytologically confirmed colon, rectal or appendiceal adenocarcinoma with synchronous or metachronous peritoneal dissemination of disease.(Stage IV peritoneal based disease only)

• Must have active measurable disease by either abdominal computerized axial tomography (CT)/ Magnetic resonance imaging (MRI) or laparoscopy.

Adequate laboratory values

• Absolute neutrophil count (ANC) > 1200/10*3/uL

• Platelet count > 140,000/10*3/uL

• Total serum bilirubin ≤ 1.5 mg/dl (patients with total bilirubin >1.5 mg/dL are eligible only with Gilbert's syndrome)

• Alkaline phosphatase < 2.5 times the upper limit of normal (ULN) (alkaline phosphatase and AST cannot both exceed the ULN)

• Aspartate aminotransferase (AST) < 1.5 times the ULN (alkaline phosphatase and AST cannot both exceed the ULN)

• Serum renal function parameters (BUN and creatinine) are within normal limits (eGFR) >50)

• Satisfactory cardiopulmonary function (as determined by Physician)

• Patients can have received prior systemic chemotherapy, radiation or surgery

• Patients must be able to undergo placement of an intraperitoneal (IP) catheter and a Port-A Cath, if not already present

• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less

• Women of reproductive age and men who are sexually active must be willing to practice effective contraception

• Patients will be allowed to have secondary malignancies as long as they do not require active concomitant treatment