Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436332
Status:
COMPLETED
Last Update Posted:
2020-04-02
First Post:
2007-02-15
Brief Title:
S0635 Erlotinib and Bevacizumab in Stage IIIB and IV Bronchioloalveolar Carcinoma
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase II Trial of the Combination of OSI-774 ERLOTINIB NSC-718781 and Bevacizumab Rhumab VEGF NSC-704865 in Stage IIIB and IV Bronchioloalveolar Carcinoma BAC and Adenocarcinoma With BAC Features ADENOBAC
Status:
COMPLETED
Status Verified Date:
2020-03
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 Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor Giving erlotinib together with bevacizumab may kill more tumor cells
PURPOSE This phase II trial is studying how well giving erlotinib together with bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer
PURPOSE This phase II trial is studying how well giving erlotinib together with bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine overall survival of patients with stage IIIB or IV bronchioloalveolar carcinoma BAC or adenocarcinoma with BAC features treated with erlotinib hydrochloride and bevacizumab
Secondary
Determine the progression-free survival of patients treated with this regimen
Compare preliminarily response as assessed by RECIST criteria vs response as assessed by a central computer-assisted image-analysis system in patients with measurable disease treated with this regimen
Assess the frequency and severity of toxicities of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral erlotinib hydrochloride once daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months for up to 2 years
PROJECTED ACCRUAL A total of 80 patients will be accrued for this study
Primary
Determine overall survival of patients with stage IIIB or IV bronchioloalveolar carcinoma BAC or adenocarcinoma with BAC features treated with erlotinib hydrochloride and bevacizumab
Secondary
Determine the progression-free survival of patients treated with this regimen
Compare preliminarily response as assessed by RECIST criteria vs response as assessed by a central computer-assisted image-analysis system in patients with measurable disease treated with this regimen
Assess the frequency and severity of toxicities of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral erlotinib hydrochloride once daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months for up to 2 years
PROJECTED ACCRUAL A total of 80 patients will be accrued for this study
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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0635 | OTHER | None | None |