Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118144
Status:
COMPLETED
Last Update Posted:
2014-08-21
First Post:
2005-07-08
Brief Title:
Bortezomib in Treating Patients With Stage IIIB or Stage IV Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Bortezomib PS-341 for Patients With Advanced Bronchiolo-Alveolar Carcinoma BAC or Adenocarcinoma With BAC Features
Status:
COMPLETED
Status Verified Date:
2013-04
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:
This phase II trial is studying how well bortezomib works in treating patients with stage IIIB or stage IV lung cancer Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I Determine the objective response rate in patients with stage IIIB or IV bronchoalveolar carcinoma BAC or adencarcinoma of the lung with BAC features treated with bortezomib
SECONDARY OBJECTIVES
I Determine the progression-free and overall survival of patients treated with this drug
II Determine the time to disease progression in patients treated with this drug
III Determine predictors of response based on molecular correlative studies of tumor and blood in patients with treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to prior epidermal growth factor receptor inhibitor therapy yes vs no
Patients receive bortezomib IV over 3-5 seconds on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for survival
I Determine the objective response rate in patients with stage IIIB or IV bronchoalveolar carcinoma BAC or adencarcinoma of the lung with BAC features treated with bortezomib
SECONDARY OBJECTIVES
I Determine the progression-free and overall survival of patients treated with this drug
II Determine the time to disease progression in patients treated with this drug
III Determine predictors of response based on molecular correlative studies of tumor and blood in patients with treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to prior epidermal growth factor receptor inhibitor therapy yes vs no
Patients receive bortezomib IV over 3-5 seconds on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for survival
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 |
|---|---|---|---|
| NCI-2009-00113 | REGISTRY | None | None |
| CDR0000433404 | None | None | None |
| PHII-57 | OTHER | None | None |
| 7003 | OTHER | None | None |
| N01CM62208 | NIH | None | None |
| N01CM62201 | NIH | None | None |
| N01CM62209 | NIH | None | None |
| N01CM62207 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62207 |