NCT00003368

Irinotecan in Treating Patients With Solid Tumors or Lymphoma Who Have Abnormal Liver or Kidney Function or Who Have Received Radiation Therapy to the Pelvis

Phase I Study of Irinotecan for Patients With Abnormal Liver or Renal Function or With Prior Pelvic Radiation Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: National Cancer Institute (NCI) · NIH
• 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. Irinotecan may be effective in treating patients with abnormal liver or kidney function or who have received radiation therapy. PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating patients with solid tumors or lymphoma who have abnormal liver or kidney function or who have had previous radiation therapy to the pelvis.

Detailed description

OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan in patients with solid tumors or lymphoma who have liver or renal dysfunction or have had prior pelvic radiation. II. Characterize the pharmacokinetics of irinotecan in these patients. OUTLINE: This is a dose escalation study. Patients are stratified according to prior pelvic radiation therapy (yes vs no). Patients with no prior pelvic radiation are further stratified according to AST, bilirubin, and creatinine levels. Patients receive irinotecan IV over 90 minutes every 3 weeks for a total of 2 courses. After patients are reevaluated, treatment may continue in the absence of disease progression or unacceptable toxicity. Cohorts of 3 to 6 patients receive escalating doses of irinotecan. Dose escalation proceeds within each stratum until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose below that at which 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 75 patients will be accrued for this study at a rate of 2-3 patients per month.

Conditions

• Lymphoma
• Small Intestine Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	irinotecan hydrochloride

Timeline

• Start date: 1998-06-01
• Completion: 2006-07-01
• First posted: 2004-03-12
• Last updated: 2013-03-21

Locations

45 sites across 1 country: United States