NCT00112892

Irinotecan and Selenium in Treating Patients With Advanced Solid Tumors

A Phase I and Pharmacokinetic Study of Selenomethionine With Fixed Dose Irinotecan in Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Selenium may allow higher doses of irinotecan to be given. Giving irinotecan together with selenium may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of selenium when given together with irinotecan in treating patients with advanced solid tumors.

Detailed description

OBJECTIVES: Primary * Determine the optimal loading and maintenance doses of selenium necessary to achieve selenium concentrations exceeding 15 μM when administered with irinotecan in patients with advanced solid tumors. Secondary * Determine the pharmacokinetics of this regimen in these patients. * Determine the toxic effects of this regimen in these patients. * Determine any observed tumor response to this regimen in these patients. OUTLINE: This is a dose-escalation study of selenium. Patients receive a loading dose\* of oral selenium twice daily on days -6 to 0. Patients then receive oral selenium once daily on days 1-42 and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. NOTE: \*The loading dose is administered prior to course 1 only. Cohorts of 3-6 patients receive escalating doses of selenium until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD. PROJECTED ACCRUAL: A total of 2-36 patients will be accrued for this study within 18 months.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	selenium
DRUG	irinotecan hydrochloride

Timeline

• Start date: 2004-08-01
• Primary completion: 2007-09-01
• Completion: 2007-12-01
• First posted: 2005-06-03
• Last updated: 2014-01-13

Locations

1 site across 1 country: United States