Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan - Full Text View

Sponsored by:	Norris Comprehensive Cancer Center
Information provided by:	Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00183859

Purpose

This is a research study for patients that have an advanced cancer that is confined mostly to the abdominal cavity and have failed treatment with conventional therapy, or for which no standard treatment exists. The purpose of this study is to determine the dose of a chemotherapy drug (called irinotecan) that can be administered safely into the abdominal cavity. We also wish to identify the side effects of irinotecan when it is administered directly into the abdomen. In this study, we will also determine the levels of irinotecan in the blood and in the abdominal cavity.

Irinotecan is a chemotherapy drug that can decrease the size of several different tumors. It is approved by the FDA for the treatment of colon cancer. It appears that some other chemotherapy drugs are more effective and may have less side effects when they are administered directly into the abdomen.

Condition	Intervention	Phase
Adenocarcinoma Gastric Cancer	Drug: irinotecan	Phase I

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Irinotecan Irinotecan hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Official Title:	Phase I Clinical and Pharmacokinetic Trial of Intra-Peritoneal Irinotecan

Further study details as provided by Norris Comprehensive Cancer Center:

Primary Outcome Measures:

To establish the maximum tolerated dose (MTD) of irinotecan when administered by an intra-peritoneal route every three weeks. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine the pharmacokinetics of intra-peritoneal irinotecan. [ Time Frame: One day ] [ Designated as safety issue: No ]
To determine the toxicity profile of intra-peritoneal irinotecan. [ Time Frame: 30 days after patient receives last dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	25
Study Start Date:	September 1999
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Intraperitoneal Irinotecan	Drug: irinotecan Intraperitoneal Irinotecan given every three weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed recurrent, metastatic, or residual cancer with disease confined mostly to the peritoneal cavity. Patients with asymptomatic extra-peritoneal disease are eligible.
Measurable or evaluable disease. Patients with malignant ascites or carcinomatosis only (documented by cytology or during surgery) are eligible. Patients with ovarian cancer and disease manifested only by an elevated CA-125 are also eligible.
Adequate hepatic, renal, and bone marrow functions: bilirubin less than or equal to 2.0 mg/dl; creatinine less than or equal to 2.0 mg/dl, alkaline phosphatase less than or equal to 3 x upper limit of normal (uln), AST or ALT less than or equal to 3 x uln; AGC greater than or equal to 1500, platelets greater than or equal to 100,000.
SWOG performance status 0-2
Fully recovered from acute toxicities from prior surgery, chemotherapy, or radiation therapy.
Patients must use an approved method of birth control.

Exclusion Criteria:

Medical, social, or psychological factors which could prevent patient from receiving treatment.
Prior therapy with intra-peritoneal irinotecan
Significant intra-peritoneal adhesions detected clinically or by prior surgical exploration

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183859

Contacts

Contact: Sarah E Cole, M.S.

323-865-0820

scole@ccnt.usc.edu

Locations

United States, California
U.S.C. / Norris Comprehensive Cancer Center	Recruiting
Los Angeles, California, United States, 90033
Contact: Sarah E Cole, M.S. 323-865-0820 scole@ccnt.usc.edu

Sponsors and Collaborators

Norris Comprehensive Cancer Center

Investigators

Principal Investigator:

Syma Iqbal, M.D.

U.S.C. / Norris Comprehensive Cancer Center

More Information

Responsible Party:	U.S.C./Norris Comprehensive Cancer Center ( Syma Iqbal, M.D. )
Study ID Numbers:	0C-99-7
Study First Received:	September 9, 2005
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00183859
Health Authority:	United States: Food and Drug Administration

Keywords provided by Norris Comprehensive Cancer Center:

solid tumor
phase I
phase one

Study placed in the following topic categories:

Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Stomach Neoplasms
Irinotecan

Gastrointestinal Neoplasms
Stomach cancer
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009