Pegfilgrastim Given Same Day As or Day After Carboplatin and Docetaxel in Advanced Metastatic Non-Small Cell Lung Cancer (NSCLC)

Completed

• Conditions: Lung Cancer; Non-Small Cell Lung Cancer
• Interventions: Other: PI Discretion

• Registration Number: NCT00094822
• Lead Sponsor: Amgen

Brief Summary

The purpose of this research study is to evaluate the safety and effectiveness of Neulasta® (pegfilgrastim) in reducing infection when given on the same day versus one day after the completion of chemotherapy (docetaxel and carboplatin) in patients with advanced or metastatic non-small cell lung cancer (NSCLC). This study is considered to be "investigational" because previous studies with Neulasta® used next day dosing and not same day dosing.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Study First Submitted QC: 2004-10-26
• Study First Submitted: 2004-10-27
• Study First Posted: 2004-10-27
• Primary Completion: 2005-12
• Study Completion: 2006-02
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-12
• Last Update Posted: 2009-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pegfilgrastim	PI Discretion	-
PLACEBO	PI Discretion	-

Primary Outcome Measures

Name	Time	Method
incidence of infection	during treatment