Treatment of Peritoneal Cancer With Surgery, Perfused Heated Cisplatin and Chemotherapy

PHASE2CompletedINTERVENTIONAL
Enrollment

188

Participants

Timeline

Start Date

January 31, 2000

Primary Completion Date

August 31, 2009

Study Completion Date

August 31, 2009

Conditions
Abdominal NeoplasmColonic NeoplasmMesotheliomaPeritoneal Neoplasm
Interventions
PROCEDURE

Surgery

Patients will undergo cytoreductive surgery to remove as much tumor as possible. Part of the intestines, pancreas, stomach or the entire spleen may also be removed if they are affected.

PROCEDURE

Continuous hyperthermic peritoneal perfusion (CHPP) with Cisplatin

DRUG

Postoperative dwell with paclitaxel and 5-FU

Intraperitoneal dwell chemotherapy with a combination of 5-FU and Paclitaxel will be delivered in the early postoperative period (day 7 today 12 after surgery). Patients will be premedicated with hydrocortisone (100 mg/intravenous push (i.v.p.)), diphenhydramine (50 mg i.v.p.) and ranitidine (50 mg i.v.p.) 30 minutes prior to delivering intraperitoneal chemotherapy. One liter of normal saline will be infused containing 5-FU (800 mg/M\^2) and 1 L of normal saline containing paclitaxel (125 mg/M\^2) will be infused over 60 minutes. The chemotherapy solution will be left in the abdominal cavity permanently for slow absorption.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT00004547 - Treatment of Peritoneal Cancer With Surgery, Perfused Heated Cisplatin and Chemotherapy | Biotech Hunter | Biotech Hunter