Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268346
Status:
COMPLETED
Last Update Posted:
2016-01-05
First Post:
2005-12-20
Brief Title:
Gefitinib in Treating Patients With Recurrent or Metastatic Esophageal or Gastroesophageal Junction Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Trial of ZD1839 IRESSA for Patients With Recurrent or Metastatic Cancer of the Esophagus or Gastroesophageal Junction
Status:
COMPLETED
Status Verified Date:
2015-12
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 some of the enzymes needed for cell growth
PURPOSE This phase II trial is studying how well gefitinib works in treating patients with recurrent or metastatic esophageal or gastroesophageal junction cancer
PURPOSE This phase II trial is studying how well gefitinib works in treating patients with recurrent or metastatic esophageal or gastroesophageal junction cancer
Detailed Description:
OBJECTIVES
Primary
Explore the activity of single agent gefitinib in terms of response rate in a patient population with recurrent or metastatic esophageal or gastroesophageal junction cancer
Secondary
Assess the toxicity of this drug in these patients
OUTLINE Patients are stratified according to prior treatment yes vs no
Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for survival
PROJECTED ACCRUAL A total of 76 patients will be accrued for this study
Primary
Explore the activity of single agent gefitinib in terms of response rate in a patient population with recurrent or metastatic esophageal or gastroesophageal junction cancer
Secondary
Assess the toxicity of this drug in these patients
OUTLINE Patients are stratified according to prior treatment yes vs no
Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for survival
PROJECTED ACCRUAL A total of 76 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 |
|---|---|---|---|
| ZENECA-1839IL0234 | Other Identifier | Cleveland Clinic IRB | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| CCF-5538 | OTHER | None | None |