Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030485
Status:
COMPLETED
Last Update Posted:
2014-01-27
First Post:
2002-02-14
Brief Title:
Erlotinib in Treating Patients With Locally Advanced andor Metastatic Endometrial Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of OSI-774 NSC 718781 in Patients With Locally Advanced andor Metastatic Carcinoma of the Endometrium
Status:
COMPLETED
Status Verified Date:
2011-01
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 erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor
PURPOSE Phase II trial to determine the effectiveness of erlotinib in treating patients who have locally advanced andor metastatic endometrial cancer
PURPOSE Phase II trial to determine the effectiveness of erlotinib in treating patients who have locally advanced andor metastatic endometrial cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of erlotinib in terms of response rate and duration of stable disease in patients with locally advanced andor metastatic carcinoma of the endometrium
Determine the toxicity of this drug in these patients
Determine the time to progression and duration of response in patients treated with this drug
Correlate objective tumor response with levels of epidermal growth factor receptor expression in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral erlotinib once daily Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks Patients with complete or partial response or stable disease are also followed every 3 months until relapse or death
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 12-18 months
Determine the efficacy of erlotinib in terms of response rate and duration of stable disease in patients with locally advanced andor metastatic carcinoma of the endometrium
Determine the toxicity of this drug in these patients
Determine the time to progression and duration of response in patients treated with this drug
Correlate objective tumor response with levels of epidermal growth factor receptor expression in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral erlotinib once daily Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks Patients with complete or partial response or stable disease are also followed every 3 months until relapse or death
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 12-18 months
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 |
|---|---|---|---|
| CDR0000069169 | OTHER | PDQ | None |
| CAN-NCIC-IND148 | None | None | None |
| NCI-NCIC-148 | None | None | None |