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

February 12, 2009 updated by: Amgen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

90

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Advanced or Metastatic NSCLC

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pegfilgrastim
Other: PI Discretion
PI Discretion
PLACEBO
Other: PI Discretion
PI Discretion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of infection
Time Frame: during treatment
during treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

October 27, 2004

First Submitted That Met QC Criteria

October 26, 2004

First Posted (Estimate)

October 27, 2004

Study Record Updates

Last Update Posted (Estimate)

February 13, 2009

Last Update Submitted That Met QC Criteria

February 12, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20030123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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