Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258297
Status:
TERMINATED
Last Update Posted:
2013-10-16
First Post:
2005-11-22
Brief Title:
Gefitinib in Treating Patients With Stage I Stage II or Stage III Esophageal Cancer That Can Be Removed By Surgery
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
A Phase II Safety Efficacy and Feasibility Study of Neoadjuvant ZD1839 IRESSA in Resectable Esophageal Cancer
Status:
TERMINATED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn for lack of funding and accrual
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 some of the enzymes needed for cell growth Giving gefitinib before surgery may shrink the tumor so that it can be removed
PURPOSE This phase II trial is studying how well gefitinib works in treating patients with stage I stage II or stage III esophageal cancer that can be removed by surgery
PURPOSE This phase II trial is studying how well gefitinib works in treating patients with stage I stage II or stage III esophageal cancer that can be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine the safety and tolerability of neoadjuvant gefitinib in patients with resectable stage I-III esophageal cancer
Secondary
Determine the epidermal growth factor-receptor expression in tissue samples obtained at diagnosis and surgery from patients treated with this drug
OUTLINE This is an open-label study
Patients receive oral gefitinib once daily beginning between days -21 and -14 and continuing until day -1 Patients undergo tumor resection on day 0
After completion of study treatment patients are followed periodically for 6 months
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Determine the safety and tolerability of neoadjuvant gefitinib in patients with resectable stage I-III esophageal cancer
Secondary
Determine the epidermal growth factor-receptor expression in tissue samples obtained at diagnosis and surgery from patients treated with this drug
OUTLINE This is an open-label study
Patients receive oral gefitinib once daily beginning between days -21 and -14 and continuing until day -1 Patients undergo tumor resection on day 0
After completion of study treatment patients are followed periodically for 6 months
PROJECTED ACCRUAL A total of 30 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 |
|---|---|---|---|
| URCC-U2203 | None | None | None |
| ZENECA-1839US0282 | None | None | None |