Two days prior to planned surgery, paclitaxel is infused IV over 24 hours.
Patients will undergo cytoreductive surgery, to debulk tumor. Scope of procedure will vary
with each patient, including a spectrum of possible procedures, such as splenectomy, liver
resection, pancreatic resection or bowel resection.
After cytoreductive surgery, continuous hyperthermic peritoneal perfusion (CHPP) surgery
with cisplatin will begin by placing an influx and efflux catheters via abdominal wall.
Perfusion rate of cisplatin is 1.5 L/min and the duration is 90 min.
Postoperative intraperitoneal chemotherapy will begin 24 hours after CHPP surgery.
Dose escalation will proceed after patients at a given dose level receive 3 courses. In
order to properly evaluate hematoxicity, a minimum of 3 weeks will be required before dose
escalation. MTD is either the dose level immediately below the level at which 2 of 6
patients in a cohort experience nonhematologic dose limiting toxicity (DLT) or when 4 of 6
patients experience hematologic DLT.
Two to 4 months after surgery, laparotomy will be conducted to determine response to
treatment. If tumor size is decreased, patients will undergo a second treatment course
identical to the same techniques and chemotherapy agents.
Peritoneal carcinomatosis is considered a terminal stage of tumor progression.
Cytoreductive surgery plus aggressive combination intraperitoneal chemotherapy may
significantly alter the natural history of this disease. This study will define the maximum
tolerated dose of paclitaxel and 5-fluorouracil (5-FU) given as an early post-operative
intraperitoneal (IP) dwell therapy after cytoreductive surgery and continuous hyperthermic
peritoneal perfusion with cisplatin (CHPP).
The patients must have an ECOG performance status of 0 or 1 and have no concomitant
medical problems that would place them at increased risk for a major surgical procedure
(EG, cardiac or pulmonary disabilities).
Patients at increased risk for coronary artery disease or cardiac dysfunction (e.g., age
greater than 65, history of hypertension, first degree relative with atherosclerotic
coronary artery disease) will undergo cardiac evaluation and performed which will include
an attempt to remove all disease greater than 0.5 cm in diameter.