Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015964
Status:
COMPLETED
Last Update Posted:
2013-09-05
First Post:
2001-05-06
Brief Title:
ZD 1839 in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Phase II Stdy of ZD 1839 in Recurrent andor Metastatic Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2013-09
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 Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of head and neck cancer
PURPOSE Phase II trial to study the effectiveness of ZD1839 in treating patients who have metastatic or recurrent cancer of the head and neck
PURPOSE Phase II trial to study the effectiveness of ZD1839 in treating patients who have metastatic or recurrent cancer of the head and neck
Detailed Description:
OBJECTIVES I Determine the activity of ZD 1839 in patients with metastatic or recurrent squamous cell carcinoma of the head and neck II Determine the effectiveness of this regimen in these patients III Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study Patients receive oral ZD 1839 once daily on days 1-28 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months
PROJECTED ACCRUAL A total of 22-46 patients will be accrued for this study within 1-2 years
OUTLINE This is a multicenter study Patients receive oral ZD 1839 once daily on days 1-28 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months
PROJECTED ACCRUAL A total of 22-46 patients will be accrued for this study within 1-2 years
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-1721 | None | None | None |
| UCCRC-10869 | None | None | None |