NCT00094822

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2003

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

October 27, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

February 13, 2009

Status Verified

February 1, 2009

Enrollment Period

2.4 years

First QC Date

October 27, 2004

Last Update Submit

February 12, 2009

Conditions

Lung CancerNon-Small Cell Lung Cancer

Keywords

Metastatic CancerNeulasta®pegfilgrastim

Outcome Measures

Primary Outcomes (1)

  • incidence of infection

    during treatment

Study Arms (2)

Pegfilgrastim

Other: PI Discretion

PLACEBO

Other: PI Discretion

Interventions

PI DiscretionOTHER

PI Discretion

PLACEBOPegfilgrastim

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Advanced or Metastatic NSCLC

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 27, 2004

First Posted

October 27, 2004

Study Start

July 1, 2003

Primary Completion

December 1, 2005

Study Completion

February 1, 2006

Last Updated

February 13, 2009

Record last verified: 2009-02