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

There are two common combinations of chemotherapy drugs used to treat cancer of the colon,
rectum, or appendix that has spread to the abdomen. One uses 5-fluorouracil (also called
5-FU), leucovorin and oxaliplatin, and is called FOLFOX. The other uses 5-FU, leucovorin, and
irinotecan, and is called FOLFIRI. The Food and Drug Administration (FDA) has approved each
of these combinations as treatment for colon or rectal cancer. Each is given through the
veins.

FOLFOX and FOLFIRI do not work well for tumors growing in the abdominal cavity. The
investigators are trying to determine if giving chemotherapy called oxaliplatin directly into
the abdominal cavity will have a greater effect on the cancer.

The FDA has approved oxaliplatin to be given to people through their veins to treat advanced
colorectal cancer. Giving oxaliplatin directly into the abdomen in this study is experimental
and is not approved by the FDA. This study will give the standard chemotherapy FOLFIRI
through the veins and oxaliplatin directly into the abdomen. This is the first time
intraperitoneal oxaliplatin is being given in combination with FOLFIRI.

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.

Adquate laboatory 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