Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026195
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2001-11-09
Brief Title:
Irinotecan in Treating Aging Patients With Solid Tumors
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
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 35 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 35 years
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068995 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CLB-60001 | None | None | None |