Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100945
Status:
COMPLETED
Last Update Posted:
2016-12-13
First Post:
2005-01-07
Brief Title:
Gefitinib in Treating Patients With Locally Advanced Esophageal Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Study Of Maintenance ZD1839 IRESSA In Patients With Locally Advanced Esophageal Cancer After Treatment Given With Curative Intent
Status:
COMPLETED
Status Verified Date:
2016-12
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 locally advanced esophageal cancer
PURPOSE This phase II trial is studying how well gefitinib works in treating patients with locally advanced esophageal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the 1-year overall survival rate in patients with previously treated locally advanced adenocarcinoma of the esophagus or gastroesophageal junction treated with gefitinib as maintenance therapy
Secondary
Determine disease-free survival and time to disease recurrence in patients treated with this drug
Determine the toxicity of this drug in these patients
Determine the quality of life of patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral gefitinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease recurrence or unacceptable toxicity
Quality of life is assessed at baseline 4 weeks every 12 weeks during study treatment and then at the end of study treatment
Patients are followed every 3 months for up to 5 years
Primary
Determine the 1-year overall survival rate in patients with previously treated locally advanced adenocarcinoma of the esophagus or gastroesophageal junction treated with gefitinib as maintenance therapy
Secondary
Determine disease-free survival and time to disease recurrence in patients treated with this drug
Determine the toxicity of this drug in these patients
Determine the quality of life of patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral gefitinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease recurrence or unacceptable toxicity
Quality of life is assessed at baseline 4 weeks every 12 weeks during study treatment and then at the end of study treatment
Patients are followed every 3 months for up to 5 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 |
|---|---|---|---|
| CDR0000407534 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02644 | REGISTRY | None | None |