Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-25 @ 4:40 PM
Study NCT ID:
NCT00150657
Status:
UNKNOWN
Last Update Posted:
2005-11-29
First Post:
2005-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer
Sponsor:
St. John Providence Health System
Organization:
Study Overview
Official Title:
Phase II Trial of Carboplatin/Gemcitabine 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 mg/M2 IV day 1,8 carboplatin AUC 5 IV day 1 bevacizumab 15 mg/kg 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 mg/M2 IV day 1,8 carboplatin AUC 5 IV day 1 bevacizumab 15 mg/kg IV day 1 repeated every 21 days for 6 cycles
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: