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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00094822
First received: October 27, 2004
Last updated: February 12, 2009
Last verified: February 2009

October 27, 2004
February 12, 2009
July 2003
December 2005   (final data collection date for primary outcome measure)
incidence of infection [ Time Frame: during treatment ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00094822 on ClinicalTrials.gov Archive Site
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Pegfilgrastim Given Same Day As or Day After Carboplatin and Docetaxel in Advanced Metastatic Non-Small Cell Lung Cancer (NSCLC)
Pegfilgrastim Given Same Day as or Day After Carboplatin and Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Advanced or Metastatic NSCLC

  • Lung Cancer
  • Non-Small Cell Lung Cancer
Other: PI Discretion
PI Discretion
  • Pegfilgrastim
    Intervention: Other: PI Discretion
  • PLACEBO
    Intervention: Other: PI Discretion
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
February 2006
December 2005   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00094822
20030123
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Global Development Leader, Amgen Inc.
Amgen
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Study Director: MD Amgen
Amgen
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP