Clinical trial NCT00183859: Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan
Official title: Phase I Clinical and Pharmacokinetic Trial of Intra-Peritoneal Irinotecan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adenocarcinoma
Gastric Cancer
Keywords: solid tumor
phase I
phase one
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To establish the maximum tolerated dose (MTD) of irinotecan when administered by an intra-peritoneal route every three weeks.
timeFrame: 6 weeks
Secondary outcomes:
measure: To determine the pharmacokinetics of intra-peritoneal irinotecan.
timeFrame: One day
measure: To determine the toxicity profile of intra-peritoneal irinotecan.
timeFrame: 30 days after patient receives last dose
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: U.S.C. / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: U.S.C. / Norris Comprehensive Cancer Center
name: Syma Iqbal, M.D.
role: PRINCIPAL_INVESTIGATOR
References: