Chemotherapy Administered Every 2 Weeks With or Without Pegfilgrastim (Neulasta) in Subjects With Advanced Colon Cancer - Full Text View

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00094809

Purpose

The purpose of this research study is to evaluate the safety and effectiveness of pegfilgrastim in reducing infection when given after one of three chemotherapy regimens (FOIL, FOLFOX or FOLFIRI) in patients with locally advanced or metastatic colorectal cancer. This study is considered to be "investigational" because the time between receiving pegfilgrastim and the next cycle of chemotherapy is only 11 days.

Condition	Intervention	Phase
Colon Cancer Colorectal Cancer Rectal Cancer	Other: Dose delay or dose reduction Drug: pegfilgrastim	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Chemotherapy Administered Every 2 Weeks With or Without a Single Injection of Pegfilgrastim as First or Second-Line Treatment in Subjects With Locally Advanced or Metastatic Colon Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Pegfilgrastim

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Grade 3 and 4 neutropenia [ Time Frame: first 4 cycles of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Dose delays [ Time Frame: first 4 cycles of treatment ] [ Designated as safety issue: No ]
Dose reductions [ Time Frame: first 4 cycles of treatment ] [ Designated as safety issue: No ]
Quality of life as measured by FACT-N, FACT-C subscale, and HADS [ Time Frame: during first 4 cycles of treatment ] [ Designated as safety issue: No ]
Febrile neutropenia [ Time Frame: first 4 cycles of treatment ] [ Designated as safety issue: Yes ]
Hospitalization rates due to a neutropenia-related event [ Time Frame: during first 4 cycles of neutropenia ] [ Designated as safety issue: No ]
Time to progression [ Time Frame: throughout end of follow up period (up to 24 months after first four cycles of treatment) ] [ Designated as safety issue: No ]
Objective response rates [ Time Frame: throughout end of follow up period (up to 24 months after first four cycles of treatment) ] [ Designated as safety issue: No ]
Survival [ Time Frame: throughout end of follow up period (up to 24 months after first four cycles of treatment) ] [ Designated as safety issue: No ]

Enrollment:	252
Study Start Date:	February 2003
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
placebo: Placebo Comparator	Other: Dose delay or dose reduction Patients not reaching protocol defined ANC at time of treatment will be dose delayed or reduced per physician discretion. Drug: pegfilgrastim Patients experiencing neutropenia can be given pegfilgrastim at the discretion of the physician
Neulasta: Active Comparator	Other: Dose delay or dose reduction Patients not reaching protocol defined ANC at time of treatment will be dose delayed or reduced per physician discretion. Drug: pegfilgrastim Patients experiencing neutropenia can be given pegfilgrastim at the discretion of the physician

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: - Diagnosis of advanced or metastatic colon cancer - Have not had any surgery within the past 2 weeks - Have not received radiation therapy within the past 4 weeks - No more than one prior chemotherapy regimen

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094809

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Locations

United States, Arkansas
Research Site
Hot Springs, Arkansas, United States
United States, California
Research Site
Santa Barbara, California, United States
Research Site
Redondo Beach, California, United States
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Oxnard, California, United States
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Pomona, California, United States
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Alhambra, California, United States
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Long Beach, California, United States
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Northridge, California, United States
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Fullerton, California, United States
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Bakersfield, California, United States
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Loma Linda, California, United States
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Vista, California, United States
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Anaheim, California, United States
United States, Colorado
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Denver, Colorado, United States
United States, District of Columbia
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Washington, District of Columbia, United States
United States, Florida
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Lakeland, Florida, United States
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Kissimmee, Florida, United States
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Titusville, Florida, United States
United States, Illinois
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Centralia, Illinois, United States
United States, Indiana
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Indianapolis, Indiana, United States
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Muncie, Indiana, United States
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New Albany, Indiana, United States
United States, Iowa
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Waterloo, Iowa, United States
United States, Kentucky
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Hazard, Kentucky, United States
United States, Louisiana
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Baton Rouge, Louisiana, United States
United States, Maryland
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
United States, Michigan
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Grand Rapids, Michigan, United States
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Flint, Michigan, United States
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Riverview, Michigan, United States
United States, Missouri
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Rolla, Missouri, United States
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Kansas City, Missouri, United States
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St. Louis, Missouri, United States
United States, Nebraska
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Fremont, Nebraska, United States
United States, Nevada
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Las Vegas, Nevada, United States
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Henderson, Nevada, United States
United States, New Hampshire
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Portsmouth, New Hampshire, United States
United States, New Jersey
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Elizabeth, New Jersey, United States
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Red Bank, New Jersey, United States
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Somerville, New Jersey, United States
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Belleville, New Jersey, United States
United States, New York
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Staten Island, New York, United States
United States, Ohio
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Dover, Ohio, United States
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Medina, Ohio, United States
United States, Oklahoma
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Oklahoma City, Oklahoma, United States
United States, Pennsylvania
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Langhorne, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Scranton, Pennsylvania, United States
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Bethlehem, Pennsylvania, United States
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Gettysburg, Pennsylvania, United States
United States, Rhode Island
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Cranston, Rhode Island, United States
United States, South Carolina
Research Site
Columbia, South Carolina, United States
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Mount Pleasant, South Carolina, United States
United States, Tennessee
Research Site
Collierville, Tennessee, United States
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Chattanooga, Tennessee, United States
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Johnson City, Tennessee, United States
Research Site
Germantown, Tennessee, United States
United States, Texas
Research Site
Houston, Texas, United States
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Laredo, Texas, United States
Research Site
Texarkana, Texas, United States
United States, Utah
Research Site
Logan, Utah, United States
United States, Virginia
Research Site
Richlands, Virginia, United States
Research Site
Arlington, Virginia, United States
Research Site
Abingdon, Virginia, United States
United States, Wisconsin
Research Site
Rhinelander, Wisconsin, United States

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20020715
Study First Received:	October 26, 2004
Last Updated:	November 19, 2009
ClinicalTrials.gov Identifier:	NCT00094809 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board; United States: Quorom Institutional Review Board; United States: Western Institutional Review Board

Keywords provided by Amgen:

Neulasta®
pegfilgrastim
Advanced
Chemotherapy

Additional relevant MeSH terms:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms

Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 25, 2009