Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025350
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2001-10-11
Brief Title:
Gefitinib in Treating Patients With Recurrent Metastatic Colorectal Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Trial of Two Dose Levels of ZD1839 Iressa NSC 715055 IND 61187 in Patients With Recurrent Colorectal Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2006-01
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 Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of recurrent metastatic colorectal cancer
PURPOSE Randomized phase II trial to compare the effectiveness of two different doses of gefitinib in treating patients who have recurrent metastatic colorectal cancer
PURPOSE Randomized phase II trial to compare the effectiveness of two different doses of gefitinib in treating patients who have recurrent metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Determine the 4-month progression-free survival rate in patients with recurrent metastatic colorectal adenocarcinoma treated with gefitinib
Determine the objective tumor response rate progression and overall survival of patients treated with this drug
Determine the toxicity of this drug in these patients
OUTLINE This is a randomized double-blind study Patients are stratified according to ECOG performance status 0-1 vs 2 baseline serum CEA less than 5 mgL vs at least 5 mgL and number of metastatic sites 1 vs 2 or more Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral gefitinib once daily twice daily on day 1 of course 1 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Arm II Patients receive a higher dose of oral gefitinib as in arm I Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 100 patients 50 per treatment arm will be accrued for this study
Determine the 4-month progression-free survival rate in patients with recurrent metastatic colorectal adenocarcinoma treated with gefitinib
Determine the objective tumor response rate progression and overall survival of patients treated with this drug
Determine the toxicity of this drug in these patients
OUTLINE This is a randomized double-blind study Patients are stratified according to ECOG performance status 0-1 vs 2 baseline serum CEA less than 5 mgL vs at least 5 mgL and number of metastatic sites 1 vs 2 or more Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral gefitinib once daily twice daily on day 1 of course 1 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Arm II Patients receive a higher dose of oral gefitinib as in arm I Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 100 patients 50 per treatment arm 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 |
|---|---|---|---|
| E-6200 | None | None | None |