Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00469976
Status:
WITHDRAWN
Last Update Posted:
2015-10-08
First Post:
2007-05-03
Brief Title:
Enzastaurin Carboplatin and Gemcitabine With or Without Bevacizumab in Treating Patients With Recurrent Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Trial of Enzastaurin Plus Carboplatin and Gemcitabine ECoG in Bevacizumab-Ineligible Patients and Enzastaurin Plus Carboplatin Gemcitabine and Bevacizumab B-ECoG in Bevacizumab-Eligible Patients With Advanced Non-Small Cell Lung Cancer NSCLC
Status:
WITHDRAWN
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
ECOG will not proceed with activation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor Drugs used in chemotherapy such as carboplatin and gemcitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing 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 Giving enzastaurin together with carboplatin and gemcitabine with or without bevacizumab may kill more tumor cells
PURPOSE This phase II trial is studying how well giving enzastaurin together with carboplatin and gemcitabine with or without bevacizumab works in treating patients with recurrent stage IIIB or stage IV non-small cell lung cancer
PURPOSE This phase II trial is studying how well giving enzastaurin together with carboplatin and gemcitabine with or without bevacizumab works in treating patients with recurrent stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the progression-free survival in patients with recurrent or stage IIIB or IV non-small cell lung cancer treated with carboplatin gemcitabine and enzastaurin with or without bevacizumab
Secondary
Determine the toxicity of this regimen in these patients
Determine the overall survival in patients treated with this regimen
Determine the response rate in patients treated with this regimen
OUTLINE This is a multicenter study Patients are assigned to 1 of 2 treatment groups based on eligibility for bevacizumab therapy
Group 1 bevacizumab-eligible Patients receive carboplatin IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and oral enzastaurin hydrochloride 3 or 4 times daily on days 1-21 in courses 1-6 and bevacizumab IV over 30-90 minutes on day 1 and oral enzastaurin hydrochloride 3 times daily on days 1-21 in all subsequent courses
Group 2 bevacizumab-ineligible Patients receive carboplatin gemcitabine hydrochloride and enzastaurin hydrochloride as in group 1 in courses 1-6 and enzastaurin hydrochloride alone 3 times daily on days 1-21 in all subsequent courses
In both groups courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for up to 5 years
PROJECTED ACCRUAL A total of 99 patients will be accrued for this study
Primary
Determine the progression-free survival in patients with recurrent or stage IIIB or IV non-small cell lung cancer treated with carboplatin gemcitabine and enzastaurin with or without bevacizumab
Secondary
Determine the toxicity of this regimen in these patients
Determine the overall survival in patients treated with this regimen
Determine the response rate in patients treated with this regimen
OUTLINE This is a multicenter study Patients are assigned to 1 of 2 treatment groups based on eligibility for bevacizumab therapy
Group 1 bevacizumab-eligible Patients receive carboplatin IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and oral enzastaurin hydrochloride 3 or 4 times daily on days 1-21 in courses 1-6 and bevacizumab IV over 30-90 minutes on day 1 and oral enzastaurin hydrochloride 3 times daily on days 1-21 in all subsequent courses
Group 2 bevacizumab-ineligible Patients receive carboplatin gemcitabine hydrochloride and enzastaurin hydrochloride as in group 1 in courses 1-6 and enzastaurin hydrochloride alone 3 times daily on days 1-21 in all subsequent courses
In both groups courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for up to 5 years
PROJECTED ACCRUAL A total of 99 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 |
|---|---|---|---|
| ECOG-E3506 | None | None | None |