Debulking and Chemotherapy With or Without Intraperitoneal Chemotherapy to Treat Peritoneal Carcinomatosis

PHASE3CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 31, 2003

Primary Completion Date

September 30, 2008

Study Completion Date

September 30, 2008

Conditions
Gastrointestinal Neoplasm
Interventions
PROCEDURE

Cytoreductive surgery

"Patients will undergo a laparotomy, surgical incision in the abdomen to assess the peritoneal cavity with cytoreductive surgery or tumor debulking, to reduce tumor size.~Drug: Post operative chemotherapy: systemic oxaliplatin 85 mg/m\^2 on day 1 only, leucovorin 200 mg/M\^2/day on day 1, 2, 15, and 16, and infusional 5-flurouracil (5-FU) 800 mg/m\^2 on day 8, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles { 16 weeks total}."

PROCEDURE

Continuous hyperthermic peritoneal perfusion (HIPEC/CHPP)

"Patients will undergo a laparotomy, surgical incision in the abdomen to assess the peritoneal cavity with cytoreductive surgery or tumor debulking, to reduce tumor size.~Followed by continuous hyperthermic peritoneal perfusion (HIPEC) with 250 mg/m\^2 cisplatin. Post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluororacil (5-FU) 800 mg/m\^2 and paclitaxel 125 mg/m\^2.~Drug: Post operative chemotherapy: systemic oxaliplatin 85 mg/m\^2 on day 1 only, leucovorin 200 mg/M\^2/day on day 1, 2, 15, and 16, and infusional 5-flurouracil (5-FU) 800 mg/m\^2 on day 8, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles { 16 weeks total}."

Trial Locations (1)

20892

National Cancer Institute (NCI), Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT00052962 - Debulking and Chemotherapy With or Without Intraperitoneal Chemotherapy to Treat Peritoneal Carcinomatosis | Biotech Hunter | Biotech Hunter