Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095836
Status:
COMPLETED
Last Update Posted:
2017-05-31
First Post:
2004-11-09
Brief Title:
Gefitinib in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer That Did Not Respond to Iodine Therapy
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Phase II Study of ZD 1839 IRESSA in Patients With Advanced Thyroid Cancer
Status:
COMPLETED
Status Verified Date:
2017-05
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 Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
PURPOSE Phase II trial to study the effectiveness of gefitinib in treating patients who have locally advanced or metastatic thyroid cancer that did not respond to iodine therapy
PURPOSE Phase II trial to study the effectiveness of gefitinib in treating patients who have locally advanced or metastatic thyroid cancer that did not respond to iodine therapy
Detailed Description:
OBJECTIVES
Primary
Determine the all-measurable-disease response rate in patients with iodine-refractory locally advanced or metastatic thyroid cancer treated with gefitinib
Secondary
Determine the toxicity of this drug in these patients
Determine progression-free and overall survival of patients treated with this drug
OUTLINE This is an open-label study
Patients receive oral gefitinib once daily Treatment continues in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 27 patients will be accrued for this study
Primary
Determine the all-measurable-disease response rate in patients with iodine-refractory locally advanced or metastatic thyroid cancer treated with gefitinib
Secondary
Determine the toxicity of this drug in these patients
Determine progression-free and overall survival of patients treated with this drug
OUTLINE This is an open-label study
Patients receive oral gefitinib once daily Treatment continues in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 27 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 |
|---|---|---|---|
| P30CA006516 | NIH | None | None |
| ZENECA-IRUSIRES0165 | OTHER | None | None |
| CDR0000393510 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA006516 |