Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004883
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2000-03-07
Brief Title:
Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Trastuzumab Herceptin for Advanced Stage IIIB IV HER2 Overexpressing Non-Small Cell Lung Cancer
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:
Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage IIIB or stage IV non-small cell lung cancer that overexpresses HER2 Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the activity of trastuzumab Herceptin in patients with stage IIIB or IV HER2-overexpressing non-small cell lung cancer
SECONDARY OBJECTIVES
I Determine the duration of response in patients treated with this regimen II Determine the toxicity of this treatment regimen in this patient population
III Assess levels of circulating HER2 and correlate with HER2 expression in this patient population
V Correlate circulating HER2 levels with non-small cell lung cancer tissue HER2 expression
OUTLINE
Patients receive trastuzumab Herceptin IV over 30-90 minutes on day 1 Treatment continues once a week in the absence of disease progression or unacceptable toxicity
Patients are followed every 8 weeks until disease progression or death
PROJECTED ACCRUAL Approximately 84 patients 42 per stratum will be accrued for this study within 175 months
I Determine the activity of trastuzumab Herceptin in patients with stage IIIB or IV HER2-overexpressing non-small cell lung cancer
SECONDARY OBJECTIVES
I Determine the duration of response in patients treated with this regimen II Determine the toxicity of this treatment regimen in this patient population
III Assess levels of circulating HER2 and correlate with HER2 expression in this patient population
V Correlate circulating HER2 levels with non-small cell lung cancer tissue HER2 expression
OUTLINE
Patients receive trastuzumab Herceptin IV over 30-90 minutes on day 1 Treatment continues once a week in the absence of disease progression or unacceptable toxicity
Patients are followed every 8 weeks until disease progression or death
PROJECTED ACCRUAL Approximately 84 patients 42 per stratum will be accrued for this study within 175 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 |
|---|---|---|---|
| CDR0000067555 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| CLB-39810 | None | None | None |
| U10CA031946 | NIH | None | None |