Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00150657
Status:
UNKNOWN
Last Update Posted:
2005-11-29
First Post:
2005-09-06
Brief Title:
Study of CarboplatinGemcitabine Plus Bevacizumab in Advanced Lung Cancer
Sponsor:
St John Providence Health System
Organization:
St John Providence Health System
Study Overview
Official Title:
Phase II Trial of CarboplatinGemcitabine Plus Bevacizumab in Advanced Non-Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
this study is being done to find out if the combination of carboplatin and gemcitabine will be more effective in the the treatment of advanced lung cancer if bevacizumab an agent that blocks tumor blood vessel formation is added
the study will measure the time to progression of patients treated with the combination we hope to show that the addition of bevacizumab improves the time to progression increases the amount of time before the disease begins to worsen
all patients receive all three drugs there is no placebo
the study will measure the time to progression of patients treated with the combination we hope to show that the addition of bevacizumab improves the time to progression increases the amount of time before the disease begins to worsen
all patients receive all three drugs there is no placebo
Detailed Description:
Patients with advanced stage IV and Stage IIIB with effusion non-small cell lung cancer with non-squamous histology good performance status and adequate organ function are eligible
Patients with brain metastases squamous histology or hemoptysis are excluded
All patients must give informed consent
Schema gemcitabine 1250 mgM2 IV day 18 carboplatin AUC 5 IV day 1 bevacizumab 15 mgkg IV day 1 repeated every 21 days for 6 cycles
Patients with brain metastases squamous histology or hemoptysis are excluded
All patients must give informed consent
Schema gemcitabine 1250 mgM2 IV day 18 carboplatin AUC 5 IV day 1 bevacizumab 15 mgkg IV day 1 repeated every 21 days for 6 cycles
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