Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-01-01 @ 12:34 AM
Study NCT ID:
NCT00026195
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2001-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Irinotecan in Treating Aging Patients With Solid Tumors
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Study Overview
Official Title:
Clinical Pharmacology In The Elderly: Prospective Evaluation Of The Pharmacokinetics, Pharmacogenetics And Pharmacodynamics Of CPT-11 And Aging
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U10CA031946 | NIH | None | https://reporter.nih.gov/quic… | View |
| CLB-60001 | None | None | View | |
| CDR0000068995 | REGISTRY | NCI Physician Data Query | View |