Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00063895
Status:
COMPLETED
Last Update Posted:
2013-01-09
First Post:
2003-07-08
Brief Title:
Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer Ovarian Cancer or Squamous Cell Carcinoma of the Head and Neck
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pharmacogenetic and Pharmacodynamic Study of Erlotinib OSI-774 Toxicity in Patients With Advanced Solid Tumors
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:
This phase III trial is studying the side effects of erlotinib and to see how well it works in treating patients with metastatic or unresectable non-small cell lung cancer ovarian cancer or squamous cell carcinoma cancer of the head and neck Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
Detailed Description:
PRIMARY OBJECTIVES
I To determine if a significant correlation exists between the length of the CA dinucleotide repeat polymorphism in the EGFR gene and observed toxicity in patients treated with OSI-774
SECONDARY OBJECTIVES
I To study the pharmacodynamic effects of OSI-774 on EGFR activity and MAP kinase signaling using skin as a surrogate tissue
II To determine if interindividual variation of OSI-774 pharmacokinetics is related to a previously described CYP3A5 genetic polymorphism
III To evaluate whether toxicity or inhibition of EGFR phosphorylation correlates with OSI-774 AUC in patients treated with OSI-774
IV To describe the observed anti-tumor response and toxicities in patients with advanced solid tumors treated with single agent fixed dose of OSI-774
OUTLINE This is a multicenter study Patients are stratified according to length of CA dinucleotide repeat polymorphism short vs medium vs long
Patients receive oral erlotinib on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
I To determine if a significant correlation exists between the length of the CA dinucleotide repeat polymorphism in the EGFR gene and observed toxicity in patients treated with OSI-774
SECONDARY OBJECTIVES
I To study the pharmacodynamic effects of OSI-774 on EGFR activity and MAP kinase signaling using skin as a surrogate tissue
II To determine if interindividual variation of OSI-774 pharmacokinetics is related to a previously described CYP3A5 genetic polymorphism
III To evaluate whether toxicity or inhibition of EGFR phosphorylation correlates with OSI-774 AUC in patients treated with OSI-774
IV To describe the observed anti-tumor response and toxicities in patients with advanced solid tumors treated with single agent fixed dose of OSI-774
OUTLINE This is a multicenter study Patients are stratified according to length of CA dinucleotide repeat polymorphism short vs medium vs long
Patients receive oral erlotinib on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| U01CA070095 | NIH | None | httpsreporternihgovquickSearchU01CA070095 |
| 12202A | None | None | None |
| U01CA069852 | NIH | None | None |