Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281866
Status:
COMPLETED
Last Update Posted:
2016-10-12
First Post:
2006-01-24
Brief Title:
Erlotinib in Treating Patients With Metastatic andor Recurrent Head and Neck Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Genotypic-Based Pharmacodynamic Evaluation of Erlotinib Erlotinib Tarceva OSI Pharmaceuticals Uniondale NY in Patients With Squamous Cell Carcinoma of the Head and Neck SCCHN
Status:
COMPLETED
Status Verified Date:
2016-10
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:
RATIONALE Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
PURPOSE This phase II trial is studying how well erlotinib works in treating patients with recurrent andor metastatic head and neck cancer
PURPOSE This phase II trial is studying how well erlotinib works in treating patients with recurrent andor metastatic head and neck cancer
Detailed Description:
OBJECTIVES
Primary
Determine the relationship between response rate and number of CA repeats in intron 1 of the epidermal growth factor receptor EGFR in patients with metastatic andor locally recurrent squamous cell carcinoma of the head and neck SCCHN treated with the EGFR inhibitor erlotinib hydrochloride
Secondary
Determine the relationship between the number of CA repeats in intron 1 of the EGFR gene and time to disease progression and survival in patients treated with this drug
Determine cutaneous and other toxicities of erlotinib hydrochloride in patients with different numbers of CA repeats in intron 1 of the EGFR gene
Compare the degree of p27 upregulation and EGFR phosphorylation in skin biopsy samples in patients with different numbers of CA repeats in intron 1 of the EGFR genes treated with this drug
Determine the relationship between erlotinib hydrochloride exposure utilizing total and unbound erlotinib hydrochloride concentrations and outcome toxicity and pharmacodynamic effects upregulation of p27 in patients with different numbers of CA repeats
OUTLINE This is a multicenter study Patients are stratified according to genotype of intron 1 of the epidermal growth factor receptor 1616 vs 1620 or 2020
Patients receive oral erlotinib hydrochloride once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 37 patients will be accrued for this study
Primary
Determine the relationship between response rate and number of CA repeats in intron 1 of the epidermal growth factor receptor EGFR in patients with metastatic andor locally recurrent squamous cell carcinoma of the head and neck SCCHN treated with the EGFR inhibitor erlotinib hydrochloride
Secondary
Determine the relationship between the number of CA repeats in intron 1 of the EGFR gene and time to disease progression and survival in patients treated with this drug
Determine cutaneous and other toxicities of erlotinib hydrochloride in patients with different numbers of CA repeats in intron 1 of the EGFR gene
Compare the degree of p27 upregulation and EGFR phosphorylation in skin biopsy samples in patients with different numbers of CA repeats in intron 1 of the EGFR genes treated with this drug
Determine the relationship between erlotinib hydrochloride exposure utilizing total and unbound erlotinib hydrochloride concentrations and outcome toxicity and pharmacodynamic effects upregulation of p27 in patients with different numbers of CA repeats
OUTLINE This is a multicenter study Patients are stratified according to genotype of intron 1 of the epidermal growth factor receptor 1616 vs 1620 or 2020
Patients receive oral erlotinib hydrochloride once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 37 patients will be accrued for this study
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 |
|---|---|---|---|
| R21CA109283 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| JHOC-J0520 | None | None | None |
| JHOC-05042801 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |