Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039182
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2002-06-06
Brief Title:
Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 NSC-718781 in Patients With Malignant Pleural Mesothelioma
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor This phase II trial is studying how well erlotinib works in treating patients with malignant mesothelioma of the lung
Detailed Description:
PRIMARY OBJECTIVES
I Determine the 1-year survival rate in patients with unresectable malignant pleural mesothelioma treated with erlotinib
II Determine the response rate in patients with measurable disease treated with this drug
III Determine the frequency and severity of toxic effects of this drug in these patients
IV Measure epidermal growth factor receptor EGFR expression EGFR gene amplification and other activation products in the EGFR signaling pathway in tumor samples and correlate with clinical outcomes in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral erlotinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 2 years and then annually for 1 year
PROJECTED ACCRUAL A total of 55 patients will be accrued for this study within 14-18 months
I Determine the 1-year survival rate in patients with unresectable malignant pleural mesothelioma treated with erlotinib
II Determine the response rate in patients with measurable disease treated with this drug
III Determine the frequency and severity of toxic effects of this drug in these patients
IV Measure epidermal growth factor receptor EGFR expression EGFR gene amplification and other activation products in the EGFR signaling pathway in tumor samples and correlate with clinical outcomes in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral erlotinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 2 years and then annually for 1 year
PROJECTED ACCRUAL A total of 55 patients will be accrued for this study within 14-18 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 |
|---|---|---|---|
| CDR0000069360 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA032102 |
| SWOG-S0218 | None | None | None |
| U10CA032102 | NIH | None | None |