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NCT Number: NCT00183859

Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan

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.

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Key information

Conditions

Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

U.S.C. / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Irinotecan

Drug

Intraperitoneal Irinotecan given every three weeks

Primary outcomes

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

    Time frame: 6 weeks

Secondary outcomes

  1. To determine the pharmacokinetics of intra-peritoneal irinotecan.

    Time frame: One day

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

    Time frame: 30 days after patient receives last dose

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

Phase I Clinical and Pharmacokinetic Trial of Intra-Peritoneal Irinotecan

Important dates

Study start
1999
Primary completion
2009
Study completion
2009
First posted
Sep 16, 2005
Registry last updated
May 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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