Irinotecan in Treating Aging Patients With Solid Tumors
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.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: irinotecan hydrochloride
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Clinical Pharmacology In The Elderly: Prospective Evaluation Of The Pharmacokinetics, Pharmacogenetics And Pharmacodynamics Of CPT-11 And Aging|
|Study Start Date:||September 2001|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00026195
Show 47 Study Locations
|Study Chair:||Stuart M. Lichtman, MD||Don Monti Comprehensive Cancer Center at North Shore University Hospital|