Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT00183859
First received: September 9, 2005
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Adenocarcinoma
Gastric Cancer
Drug: irinotecan
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Clinical and Pharmacokinetic Trial of Intra-Peritoneal Irinotecan

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • To establish the maximum tolerated dose (MTD) of irinotecan when administered by an intra-peritoneal route every three weeks. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the pharmacokinetics of intra-peritoneal irinotecan. [ Time Frame: One day ] [ Designated as safety issue: No ]
  • To determine the toxicity profile of intra-peritoneal irinotecan. [ Time Frame: 30 days after patient receives last dose ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: September 1999
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Intraperitoneal Irinotecan
Drug: irinotecan
Intraperitoneal Irinotecan given every three weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183859

Locations
United States, California
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
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00183859     History of Changes
Other Study ID Numbers: 0C-99-7
Study First Received: September 9, 2005
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Southern California:
solid tumor
phase I
phase one

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Irinotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014