Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan

NCT ID: NCT00183859

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-09-30
• Study Completion Date: 2009-04-30

Brief Summary

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.

Conditions

Adenocarcinoma; Gastric Cancer

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Intraperitoneal Irinotecan

Group Type: EXPERIMENTAL

irinotecan

Intervention Type: DRUG

Intraperitoneal Irinotecan given every three weeks

Interventions

irinotecan

Intraperitoneal Irinotecan given every three weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Syma Iqbal, M.D.

Role: PRINCIPAL_INVESTIGATOR

U.S.C. / Norris Comprehensive Cancer Center

Locations

U.S.C. / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

0C-99-7

Identifier Type: -

Identifier Source: org_study_id