Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075439
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2004-01-09
Brief Title:
Gefitinib in Treating Patients With Progressive Metastatic Neuroendocrine Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of ZD1839 Iressa in Metastatic Neuroendocrine Tumors
Status:
COMPLETED
Status Verified Date:
2013-06
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 II trial is studying how well gefitinib works in treating patients with progressive metastatic neuroendocrine tumors Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
Detailed Description:
PRIMARY OBJECTIVES
I To determine the 6 month progression free survival rate in patients with progressive advanced neuroendocrine tumors treated with ZD1839
SECONDARY OBJECTIVES
I Objective tumor response rate II Progression free survival and time to progression III Improvement in circulating hormone levels IV Overall survival V We will explore the molecular characterization of these tumors in attempt to understand the role of EGFR expression and its inhibition with ZD1839 in neuroendocrine tumors The measurements will be performed on pretreatment and post-treatment tumor biopsies when possible EGFR expression and gene amplification IHC for EGFR and phosphorylated EGFR ISH for gene amplification Activation of the RasRafMAPK pathway IHC for phosphorylated MAPK Cell proliferation Ki-67 staining Apoptosis TUNEL assay
OUTLINE This is a multicenter study Patients are stratified according to disease type carcinoid vs islet cell and other neuroendocrine tumors
Patients receive oral gefitinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then every 6 months for up to 2 years from study entry
I To determine the 6 month progression free survival rate in patients with progressive advanced neuroendocrine tumors treated with ZD1839
SECONDARY OBJECTIVES
I Objective tumor response rate II Progression free survival and time to progression III Improvement in circulating hormone levels IV Overall survival V We will explore the molecular characterization of these tumors in attempt to understand the role of EGFR expression and its inhibition with ZD1839 in neuroendocrine tumors The measurements will be performed on pretreatment and post-treatment tumor biopsies when possible EGFR expression and gene amplification IHC for EGFR and phosphorylated EGFR ISH for gene amplification Activation of the RasRafMAPK pathway IHC for phosphorylated MAPK Cell proliferation Ki-67 staining Apoptosis TUNEL assay
OUTLINE This is a multicenter study Patients are stratified according to disease type carcinoid vs islet cell and other neuroendocrine tumors
Patients receive oral gefitinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then every 6 months for up to 2 years from study entry
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 |
|---|---|---|---|
| N01CM62205 | NIH | None | httpsreporternihgovquickSearchN01CM62205 |
| MC0279 | None | None | None |