Pegfilgrastim Given Same Day As or Day After Carboplatin... | NCT00094822

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

NCT00094822

Sponsor

Amgen

Status

Completed

Last Update Posted

Feb 13, 2009Estimated

Enrollment

90Actual

Phase

Not provided

Conditions

Lung Cancer
Non-Small Cell Lung Cancer

Interventions

PI Discretion

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2003

Primary Completion Date

Dec 2005Actual

Completion Date

Feb 2006Actual

First Submitted Date

Oct 27, 2004

First Submission Date that Met QC Criteria

Oct 26, 2004

First Posted Date

Oct 27, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2009

Last Update Posted Date

Feb 13, 2009Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pegfilgrastim			Other: PI Discretion
PLACEBO			Other: PI Discretion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PI Discretion	Other	PI Discretion	PLACEBO Pegfilgrastim

Measure	Description	Time Frame
incidence of infection		during treatment

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Advanced or Metastatic NSCLC

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
MD	Amgen	Study Director

References Module

Citations

Not provided

Label	URL
AmgenTrials clinical trials website	View source
FDA-approved Drug Labeling	View source

ID	Term
D008175	Lung Neoplasms
D002289	Carcinoma, Non-Small-Cell Lung
D009362	Neoplasm Metastasis

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms