Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan

This study has been completed.
Sponsor:
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT00183859
First received: September 9, 2005
Last updated: July 24, 2009
Last verified: July 2009

September 9, 2005
July 24, 2009
September 1999
April 2009   (final data collection date for primary outcome measure)
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 ]
To establish the maximum tolerated dose (MTD) of irinotecan when administered by an intra-peritoneal route every three weeks.
Complete list of historical versions of study NCT00183859 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To determine the pharmacokinetics of intra-peritoneal irinotecan.
  • To determine the toxicity profile of intra-peritoneal irinotecan.
Not Provided
Not Provided
 
Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan
Phase I Clinical and Pharmacokinetic Trial of Intra-Peritoneal 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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Adenocarcinoma
  • Gastric Cancer
Drug: irinotecan
Intraperitoneal Irinotecan given every three weeks
Experimental: A
Intraperitoneal Irinotecan
Intervention: Drug: irinotecan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
April 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00183859
0C-99-7
Not Provided
Syma Iqbal, M.D., U.S.C./Norris Comprehensive Cancer Center
University of Southern California
Not Provided
Principal Investigator: Syma Iqbal, M.D. U.S.C. / Norris Comprehensive Cancer Center
University of Southern California
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP