Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan

Sponsor

University of Southern California (Other)

Overall Status

Completed

CT.gov ID

NCT00183859

Collaborator

(none)

Enrollment

Location

Arm

115

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Adenocarcinoma Gastric Cancer	Drug: irinotecan	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I Clinical and Pharmacokinetic Trial of Intra-Peritoneal Irinotecan

Study Start Date :

Sep 1, 1999

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Intraperitoneal Irinotecan	Drug: irinotecan Intraperitoneal Irinotecan given every three weeks

Arm

Intervention/Treatment

Experimental: A

Intraperitoneal Irinotecan

Drug: irinotecan

Intraperitoneal Irinotecan given every three weeks

Outcome Measures

Primary Outcome Measures

To establish the maximum tolerated dose (MTD) of irinotecan when administered by an intra-peritoneal route every three weeks. [6 weeks]

Secondary Outcome Measures

To determine the pharmacokinetics of intra-peritoneal irinotecan. [One day]
To determine the toxicity profile of intra-peritoneal irinotecan. [30 days after patient receives last dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	U.S.C. / Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033

Sponsors and Collaborators

University of Southern California

Investigators

Principal Investigator: Syma Iqbal, M.D., U.S.C. / Norris Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Southern California

ClinicalTrials.gov Identifier:

NCT00183859

Other Study ID Numbers:

0C-99-7

First Posted:

Sep 16, 2005

Last Update Posted:

May 22, 2014

Last Verified:

May 1, 2014

Keywords provided by University of Southern California

solid tumor

phase I

phase one

Additional relevant MeSH terms:

Adenocarcinoma

Irinotecan

Study Results

No Results Posted as of May 22, 2014