Clinical Pharmacology In The Elderly: Prospective Evaluation Of The Pharmacokinetics, Pharmacogenetics And Pharmacodynamics Of CPT-11 And Aging
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.
Interventional
Primary Purpose: Treatment
Stuart M. Lichtman, MD
Study Chair
Don Monti Comprehensive Cancer Center at North Shore University Hospital
United States: Federal Government
CDR0000068995
NCT00026195
September 2001
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
Vermont Cancer Center | Burlington, Vermont 05401-3498 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
Mount Sinai Medical Center, NY | New York, New York 10029 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Lombardi Cancer Center | Washington, District of Columbia 20007 |
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
Green Mountain Oncology Group | Rutland, Vermont 05701 |
Veterans Affairs Medical Center - White River Junction | White River Junction, Vermont 05009 |
MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
North Shore University Hospital | Manhasset, New York 11030 |
Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
Holden Comprehensive Cancer Center | Iowa City, Iowa 52242-1009 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia, Missouri 65201 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
Veterans Affairs Medical Center - Durham | Durham, North Carolina 27705 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201-1595 |
University of Massachusetts Memorial Medical Center - University Campus | Worcester, Massachusetts 01655 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Weill Medical College of Cornell University | New York, New York 10021 |
Lifespan: The Miriam Hospital | Providence, Rhode Island 02906 |
Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |