Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050674
Status:
COMPLETED
Last Update Posted:
2012-12-27
First Post:
2002-12-17
Brief Title:
Docetaxel and Gemcitabine With Filgrastim-SD01 Support in Patients With Advanced Non-Small Cell Lung Carcinoma
Sponsor:
Schwartzberg Lee MD
Organization:
Schwartzberg Lee MD
Study Overview
Official Title:
Docetaxel and Gemcitabine With Filgrastim-SD01 Support in Patients With Advanced Non-Small Cell Lung Carcinoma
Status:
COMPLETED
Status Verified Date:
2012-12
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:
Determine whether patients have a decreased incidence of grade 3 and grade 4 neutropenia when Filgrastim-SD01 is given with docetaxel and gemcitabine in patients with advanced non-small cell lung cancer
Detailed Description:
Docetaxel and Gemcitabine given on day 1 and 8 of a 21-day schedule has substantial activity in non-small cell lung cancer Both first and second-line patients have response rates comparable to or better than other standard combination regimens Grade 34 neutropenia occurs in up to half of patients not given growth factor support
Studies demonstrate that a single dose of Filgrastim-SF01 at 100 mgkg effectively enhances post chemotherapy neutrophil recovery in a manner similar to that of daily Filgrastim This current study is designed to characterize the incidence of grade 34 neutropenia when a fixed dose of Filgrastim-SD01 is added to a well-studied myelosuppressive chemotherapy regimen consisting of Gemcitabine and Docetaxel
Studies demonstrate that a single dose of Filgrastim-SF01 at 100 mgkg effectively enhances post chemotherapy neutrophil recovery in a manner similar to that of daily Filgrastim This current study is designed to characterize the incidence of grade 34 neutropenia when a fixed dose of Filgrastim-SD01 is added to a well-studied myelosuppressive chemotherapy regimen consisting of Gemcitabine and Docetaxel
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