Phase I Study of OSI-774 (NSC 718781) for Solid Tumors in Patients With Hepatic or Renal Dysfunction
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.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) of OSI-774 determined by dose-limiting toxicities
Within the first 4 weeks treatment
Yes
Antonius Miller
Principal Investigator
Cancer and Leukemia Group B
United States: Food and Drug Administration
NCI-2012-01868
NCT00030498
December 2001
Name | Location |
|---|---|
| Cancer and Leukemia Group B | Chicago, Illinois 60606 |
