Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan

Gastric Cancer Clinical Trial

Official title:

Phase I Clinical and Pharmacokinetic Trial of Intra-Peritoneal Irinotecan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00183859
• Other study ID #: 0C-99-7
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2005
• Last updated: May 20, 2014
• Start date: September 1999
• Est. completion date: April 2009

Study information

• Verified date: May 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Cancer

Intervention

Drug:
• irinotecan
Intraperitoneal Irinotecan given every three weeks

Locations

Country	Name	City	State
United States	U.S.C. / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish the maximum tolerated dose (MTD) of irinotecan when administered by an intra-peritoneal route every three weeks.		6 weeks	Yes
Secondary	To determine the pharmacokinetics of intra-peritoneal irinotecan.		One day	No
Secondary	To determine the toxicity profile of intra-peritoneal irinotecan.		30 days after patient receives last dose	Yes