Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00404703
Status:
TERMINATED
Last Update Posted:
2016-08-24
First Post:
2006-11-28
Brief Title:
A Study of Avastin Bevacizumab in Combination With Platinum-Based Chemotherapy in Patients With Advanced or Recurrent Squamous Non-Small Cell Lung Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open Label Study of the Safety of First-line Treatment With Avastin in Combination With Cisplatin-gemcitabine or Carboplatin-paclitaxel in Patients With Advanced or Recurrent Squamous Non-small Cell Lung Cancer Who Are Considered to be at High Risk of Pulmonary Haemorrhage
Status:
TERMINATED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Primary safety endpoint reached
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This single arm study will assess the feasibility of using Avastin plus platinum-based chemotherapy cisplatin-gemcitabine or carboplatin-paclitaxel in patients with advanced or recurrent squamous non-small cell lung cancer who have not received prior chemotherapy Patients will receive preventive radiation followed by one cycle of chemotherapy alone and 5 cycles of chemotherapy in combination with Avastin 15mgkg iv on day 1 of each 3 weekly cycle followed by Avastin alone for a maximum total treatment period with Avastin of 12 months The anticipated time on study treatment is 3-12 months and the target sample size is 100 individuals
Detailed Description:
None
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