Trial of Intraperitoneal (IP) Oxaliplatin in Combination With Intravenous FOLFIRI (NCT02833753) | Clinical Trial Compass
CompletedPhase 1
Trial of Intraperitoneal (IP) Oxaliplatin in Combination With Intravenous FOLFIRI
United States14 participantsStarted 2016-07
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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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 C…
What they're measuring
1
Define the maximum tolerated dose (MTD) of intraperitoneal (IP) oxaliplatin given with systemic FOLFIRI in patients with peritoneal carcinomatosis (PC) of colorectal or appendiceal origin