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Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan

Primary Purpose

Adenocarcinoma, Gastric Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
irinotecan
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma focused on measuring solid tumor, phase I, phase one

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • U.S.C. / Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Intraperitoneal Irinotecan

Outcomes

Primary Outcome Measures

To establish the maximum tolerated dose (MTD) of irinotecan when administered by an intra-peritoneal route every three weeks.

Secondary Outcome Measures

To determine the pharmacokinetics of intra-peritoneal irinotecan.
To determine the toxicity profile of intra-peritoneal irinotecan.

Full Information

First Posted
September 9, 2005
Last Updated
May 20, 2014
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT00183859
Brief Title
Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan
Official Title
Phase I Clinical and Pharmacokinetic Trial of Intra-Peritoneal Irinotecan
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma, Gastric Cancer
Keywords
solid tumor, phase I, phase one

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Intraperitoneal Irinotecan
Intervention Type
Drug
Intervention Name(s)
irinotecan
Intervention Description
Intraperitoneal Irinotecan given every three weeks
Primary Outcome Measure Information:
Title
To establish the maximum tolerated dose (MTD) of irinotecan when administered by an intra-peritoneal route every three weeks.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
To determine the pharmacokinetics of intra-peritoneal irinotecan.
Time Frame
One day
Title
To determine the toxicity profile of intra-peritoneal irinotecan.
Time Frame
30 days after patient receives last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syma Iqbal, M.D.
Organizational Affiliation
U.S.C. / Norris Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
U.S.C. / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

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Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan

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