Clinical Trials Directory

Trials / Completed

CompletedNCT00030498

Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction

Phase I Study of OSI-774 (NSC 718781) for Solid Tumors in Patients With Hepatic or Renal Dysfunction

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
75 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Phase I trial to study the effectiveness of erlotinib in treating patients who have metastatic or unresectable solid tumors and liver or kidney dysfunction. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor

Detailed description

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of erlotinib in patients with solid tumors and hepatic or renal dysfunction. II. Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to hepatic or renal dysfunction (albumin less than 2.5 g/dL, direct bilirubin less than 1.0 mg/dL, any AST, and creatinine normal vs direct bilirubin 1.0-7.0 mg/dL, any AST, and creatinine normal vs creatinine 2.5-5.0 mg/dL, albumin 2.5 g/dL or greater, AST less than 3 times upper limit of normal, and direct bilirubin less than 1.0 mg/dL). Patients receive oral erlotinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 6 evaluable patients are treated at that dose.

Conditions

Interventions

TypeNameDescription
DRUGerlotinib hydrochlorideGiven orally
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2001-12-01
Primary completion
2007-07-01
First posted
2003-01-27
Last updated
2013-01-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00030498. Inclusion in this directory is not an endorsement.