Irinotecan in Treating Aging Patients With Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Registration Number
- NCT00026195
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Aging may affect the way these drugs work.
PURPOSE: Phase I trial to determine the relationship between aging and the effectiveness of irinotecan in treating patients who have solid tumors.
- Detailed Description
OBJECTIVES:
* Determine whether there is a relationship between the pharmacokinetic characteristics of irinotecan and aging in patients with non-hematologic malignancies.
* Determine whether there is a relationship between the toxic effects of this drug and aging in these patients.
* Determine whether the relationship between genotype (UGT1A1, CYP3A, and other relevant genes) and phenotype (pharmacokinetics, toxicity) is affected by aging in these patients treated with this drug.
* Analyze data collected on the co-morbid conditions and concurrent medications in these patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to age (18 to 55 vs 70 and over).
Patients receive irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 140 patients (70 per stratum) will be accrued for this study within 3.5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description irinotecan irinotecan hydrochloride Patients receive irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for survival.
- Primary Outcome Measures
Name Time Method overall survival Up to 10 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (47)
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
MBCCOP - University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
🇺🇸Columbia, Missouri, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Veterans Affairs Medical Center - Durham
🇺🇸Durham, North Carolina, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Lifespan: The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Missouri Baptist Cancer Center
🇺🇸Saint Louis, Missouri, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Veterans Affairs Medical Center - Buffalo
🇺🇸Buffalo, New York, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
Lombardi Cancer Center
🇺🇸Washington, District of Columbia, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Veterans Affairs Medical Center - White River Junction
🇺🇸White River Junction, Vermont, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
University of Massachusetts Memorial Medical Center - University Campus
🇺🇸Worcester, Massachusetts, United States
Green Mountain Oncology Group
🇺🇸Bennington, Vermont, United States