NCT00026195

Irinotecan in Treating Aging Patients With Solid Tumors

Clinical Pharmacology In The Elderly: Prospective Evaluation Of The Pharmacokinetics, Pharmacogenetics And Pharmacodynamics Of CPT-11 And Aging

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	irinotecan hydrochloride

Timeline

• Start date: 2001-09-01
• Primary completion: 2006-06-01
• Completion: 2006-06-01
• First posted: 2003-01-27
• Last updated: 2016-07-06

Locations

47 sites across 1 country: United States