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:
Amgen
ClinicalTrials.gov Identifier:
NCT00094822
First Posted: October 27, 2004
Last Update Posted: February 13, 2009
Information provided by:
Amgen
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Purpose
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.
| Condition | Intervention |
|---|---|
| Lung Cancer Non-Small Cell Lung Cancer | Other: PI Discretion |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Pegfilgrastim Given Same Day as or Day After Carboplatin and Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
U.S. FDA Resources
Further study details as provided by Amgen:
Primary Outcome Measures:
- incidence of infection [ Time Frame: during treatment ]
| Enrollment: | 90 |
| Study Start Date: | July 2003 |
| Study Completion Date: | February 2006 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Pegfilgrastim |
Other: PI Discretion
PI Discretion
|
| PLACEBO |
Other: PI Discretion
PI Discretion
|
Eligibility
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Advanced or Metastatic NSCLC
Criteria
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
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00094822
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00094822 History of Changes |
| Other Study ID Numbers: |
20030123 |
| First Submitted: | October 27, 2004 |
| First Posted: | October 27, 2004 |
| Last Update Posted: | February 13, 2009 |
| Last Verified: | February 2009 |
Keywords provided by Amgen:
|
Metastatic Cancer Neulasta® pegfilgrastim |
Additional relevant MeSH terms:
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic |
Bronchial Neoplasms Docetaxel Carboplatin Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |