Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030498
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2002-02-14
Brief Title:
Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of OSI-774 NSC 718781 for Solid Tumors in Patients With Hepatic or Renal Dysfunction
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 25 gdL direct bilirubin less than 10 mgdL any AST and creatinine normal vs direct bilirubin 10-70 mgdL any AST and creatinine normal vs creatinine 25-50 mgdL albumin 25 gdL or greater AST less than 3 times upper limit of normal and direct bilirubin less than 10 mgdL
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
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 25 gdL direct bilirubin less than 10 mgdL any AST and creatinine normal vs direct bilirubin 10-70 mgdL any AST and creatinine normal vs creatinine 25-50 mgdL albumin 25 gdL or greater AST less than 3 times upper limit of normal and direct bilirubin less than 10 mgdL
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000069170 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| CALGB-60101 | None | None | None |
| U10CA031946 | NIH | None | None |