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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00094822
Other study ID # 20030123
Secondary ID
Status Completed
Phase N/A
First received October 27, 2004
Last updated February 12, 2009
Start date July 2003
Est. completion date February 2006

Study information

Verified date February 2009
Source Amgen
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date February 2006
Est. primary completion date December 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Eligibility Criteria: - Age 18 years or older - Diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) - Have not received any prior chemotherapy - Have not received radiation therapy or undergone major surgery within the past 2 weeks

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Other:
PI Discretion
PI Discretion

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Outcome

Type Measure Description Time frame Safety issue
Primary incidence of infection during treatment No
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