Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan

Study Overview
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Brief Summary
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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.

Official Title
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Phase I Clinical and Pharmacokinetic Trial of Intra-Peritoneal Irinotecan

Conditions
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Adenocarcinoma, Gastric Cancer

Intervention / Treatment
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* Drug: irinotecan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Intraperitoneal Irinotecan | Drug: irinotecan<br>* Intraperitoneal Irinotecan given every three weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the maximum tolerated dose (MTD) of irinotecan when administered by an intra-peritoneal route every three weeks. |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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solid tumor, phase I, phase one