Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032123
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2002-03-08
Brief Title:
Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Of OSI-774 NSC 718781 In Unresectable Or Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction
Status:
COMPLETED
Status Verified Date:
2003-10
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 erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor
PURPOSE Phase II trial to study the effectiveness of erlotinib in treating patients who have locally advanced or metastatic stomach cancer or cancer of the gastroesophageal junction
PURPOSE Phase II trial to study the effectiveness of erlotinib in treating patients who have locally advanced or metastatic stomach cancer or cancer of the gastroesophageal junction
Detailed Description:
OBJECTIVES
Determine the overall response rate of patients with locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with erlotinib Gastric stratum temporarily closed to accrual as of 03012003
Determine the frequency and severity of toxic effects of this drug in these patients
Determine the overall survival and time to treatment failure in patients treated with this drug
Determine the value of intratumoral expression of epidermal growth factor receptor in predicting patient response to this drug
OUTLINE This is a multicenter study Patients are stratified according to cancer site stomach vs gastroesophageal junction The gastric stratum is temporarily closed to accrual as of 03-01-2003
Patients receive oral erlotinib once daily Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 3 years
PROJECTED ACCRUAL A total of 40-80 patients 20-40 per stratum will be accrued for this study within 14-40 months The gastric stratum is temporarily closed to accrual as of 03-01-2003
Determine the overall response rate of patients with locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with erlotinib Gastric stratum temporarily closed to accrual as of 03012003
Determine the frequency and severity of toxic effects of this drug in these patients
Determine the overall survival and time to treatment failure in patients treated with this drug
Determine the value of intratumoral expression of epidermal growth factor receptor in predicting patient response to this drug
OUTLINE This is a multicenter study Patients are stratified according to cancer site stomach vs gastroesophageal junction The gastric stratum is temporarily closed to accrual as of 03-01-2003
Patients receive oral erlotinib once daily Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 3 years
PROJECTED ACCRUAL A total of 40-80 patients 20-40 per stratum will be accrued for this study within 14-40 months The gastric stratum is temporarily closed to accrual as of 03-01-2003
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SWOG-S0127 | None | None | None |