Protocol Number: 03-C-0085

Title:

A Prospective Random Assignment Trial to Study Operative Debuking and Systemic Chemotherapy with or without Intra-and Peri-Operative Intraperitoneal Chemotherapy for Subjects with Peritoneal Carcinomatosis from Low Grade Gastrointestinal Adenocarcinoma

Number:

03-C-0085

Summary:

Background:

-There is no standard treatment for peritoneal carcinomatosis (gastrointestinal cancer that has spread throughout the abdomen).

-NCI has been developing a treatment for peritoneal carcinomatosis that involves tumor debulking (removal of as much tumor as possible) and continuous hyperthermic peritoneal perfusion (CHPP, heated chemotherapy given directly into the abdominal cavity).

Objectives:

-To determine whether tumor debulking plus CCHP using the anti-cancer drug cisplatin during surgery, followed by one dose of chemotherapy 7 to 12 days after surgery is more beneficial than tumor debulking alone.

Eligibility:

-Patients 18 years of age or older with peritoneal carcinomatosis secondary to gastrointestinal cancer.

-Cancer confined to the abdominal cavity.

Design:

-Patients are randomly assigned to undergo tumor debulking with CHPP or without CHPP.

-All patients undergo laparotomy and tumor debulking. Laparotomy entails an incision in the abdomen through which the surgeon can see the amount and location of tumors in the abdomen, and complete the removal of all tumor.

-After tumor debulking, patients in the CHPP group are given cisplatin. The drug is warmed to 104 to 107° (Degree)F and bathed over the inside of the abdomen for 90 minutes. At the end of the procedure, a small catheter is left in the abdomen for delivery of chemotherapy with 5-fluorouracil (5-FU) and paclitaxel on a day between day 7 and day 12 after surgery.

-All patients receive intravenous (through a vein) chemotherapy with oxaliplatin, 5-FU, and leucovorin after recovery from the surgery.

-Patients are evaluated at NIH 6 weeks after the surgery, at the end of the intravenous chemotherapy, then every 3 months for the first year, every 4 months for the next 2 years, and every 6 months for up to 5 years after the end of treatment. They are then offered follow-up at yearly intervals.

-A total of 74 patients will be randomized to the two treatment arms.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Appendiceal Cancer

Regional Therapy

Carcinomatosis

Hyperthermia

Recruitment Keyword(s):

None

Condition(s):

Gastrointestinal Neoplasm

Investigational Drug(s):

None

Investigational Device(s):

None

Interventions:

Procedure/Surgery: Laparotomy

Procedure/Surgery: Continuous hyperthermic peritoneal perfusion (CHPP)

Drug: Cisplatin

Drug: Fluorouracil

Drug: Paciltaxel

Drug: Oxaliplatin

Drug: Leucovorin

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Bartlett DL, Buell JF, Libutti SK, Reed E, Lee KB, Figg WD, Venzon DJ, Alexander HR. A phase I trial of continuous hyperthermic peritoneal perfusion with tumor necrosis factor and cisplatin in the treatment of peritoneal carcinomatosis. Cancer. 1998 Sep 15;83(6):1251-61.

de Gramont A, Figer A, Seymour M, Homerin M, Hmissi A, Cassidy J, Boni C, Cortes-Funes H, Cervantes A, Freyer G, Papamichael D, Le Bail N, Louvet C, Hendler D, de Braud F, Wilson C, Morvan F, Bonetti A. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol. 2000 Aug;18(16):2938-47.

Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, Jandik P, Iveson T, Carmichael J, Alakl M, Gruia G, Awad L, Rougier P. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet. 2000 Mar 25;355(9209):1041-7.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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