Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024089
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2001-09-13
Brief Title:
Gefitinib in Treating Patients With Recurrent andor Metastatic Head and Neck Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of ZD 1839 Iressa in Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2005-11
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 II trial to study the effectiveness of gefitinib in treating patients who have recurrent andor metastatic head and neck cancer Biological therapies such as gefitinib may interfere with the growth of tumor cells by blocking an enzyme necessary for cell growth
Detailed Description:
OBJECTIVES
I Determine the disease control rate in terms of complete response partial response and stable disease for at least 4 months in patients with recurrent andor metastatic squamous cell cancer of the head and neck treated with gefitinib
II Determine the effect of this drug on epidermal growth factor receptor phosphorylation and expression of selected genes in these patients
III Determine the toxic effects of this drug in these patients
OUTLINE Patients are stratified as delineated in the Disease Characteristics
Patients receive oral gefitinib daily Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
I Determine the disease control rate in terms of complete response partial response and stable disease for at least 4 months in patients with recurrent andor metastatic squamous cell cancer of the head and neck treated with gefitinib
II Determine the effect of this drug on epidermal growth factor receptor phosphorylation and expression of selected genes in these patients
III Determine the toxic effects of this drug in these patients
OUTLINE Patients are stratified as delineated in the Disease Characteristics
Patients receive oral gefitinib daily Treatment repeats 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 |
|---|---|---|---|
| NCI-1701 | None | None | None |
| UUMC-8429-01 | None | None | None |