NCT00054288

Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors

Escalating Irinotecan (CPT-11) Administered 24 Hours Prior To Gemcitabine In Patients With Refractory Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Roswell Park Cancer Institute · 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining irinotecan with gemcitabine in treating patients who have refractory advanced solid tumors.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose of irinotecan when administered with gemcitabine in patients with refractory advanced solid tumors. * Determine the antitumor activity and toxicity of this regimen in these patients. * Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients. * Determine the optimal dose and time interval for this regimen in these patients. OUTLINE: This is an open-label, non-randomized, dose-escalation study of irinotecan. Patients receive irinotecan IV over 90 minutes on days 1 and 8 and gemcitabine IV over 30 minutes on days 2 and 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 8 weeks. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	gemcitabine hydrochloride
DRUG	irinotecan hydrochloride

Timeline

• Start date: 2001-08-01
• Primary completion: 2003-05-01
• Completion: 2009-06-01
• First posted: 2003-02-06
• Last updated: 2014-01-13

Locations

1 site across 1 country: United States