Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00001569

Purpose

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.

Condition	Intervention	Phase
Carcinoma Peritoneal Neoplasm	Drug: Cisplatin Drug: Paclitaxel Drug: 5-FU	Phase I

Study Type:	Interventional
Study Design:	Treatment, Safety Study
Official Title:	Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fever Surgery

Drug Information available for: Fluorouracil Cisplatin Paclitaxel

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	74
Study Start Date:	January 1997
Estimated Study Completion Date:	December 2002

Detailed Description:

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).

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001569

Locations

United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Cancer Institute (NCI)

More Information

Publications:

Fujimoto S, Shrestha RD, Kokubun M, Ohta M, Takahashi M, Kobayashi K, Kiuchi S, Okui K, Miyoshi T, Arimizu N, et al. Intraperitoneal hyperthermic perfusion combined with surgery effective for gastric cancer patients with peritoneal seeding. Ann Surg. 1988 Jul;208(1):36-41.

Sugarbaker PH, Gianola FJ, Speyer JC, Wesley R, Barofsky I, Meyers CE. Prospective, randomized trial of intravenous versus intraperitoneal 5-fluorouracil in patients with advanced primary colon or rectal cancer. Surgery. 1985 Sep;98(3):414-22.

Dedrick RL, Myers CE, Bungay PM, DeVita VT Jr. Pharmacokinetic rationale for peritoneal drug administration in the treatment of ovarian cancer. Cancer Treat Rep. 1978 Jan;62(1):1-11.

Study ID Numbers:	970072, 97-C-0072
Study First Received:	November 3, 1999
Last Updated:	March 3, 2008
ClinicalTrials.gov Identifier:	NCT00001569 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Gastrointestinal
Adenocarcinoma
Taxol

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Cisplatin
Therapeutic Uses
Peritoneal Diseases
Digestive System Neoplasms
Neoplasms by Histologic Type
Mitosis Modulators
Antimitotic Agents

Abdominal Neoplasms
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Paclitaxel
Fluorouracil
Tubulin Modulators
Peritoneal Neoplasms
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009