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

Tracking Information

First Received Date ^ICMJE

October 26, 2004

Last Updated Date

September 17, 2009

Start Date ^ICMJE

February 2003

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Grade 3 and 4 neutropenia in the first 4 cycles of treatment

Change History

Complete list of historical versions of study NCT00094809 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Dose delays
Dose reductions
Quality of life as measured by FACT-N, FACT-C subscale, and HADS
Febrile neutropenia
Hospitalization rates due to a neutropenia-related event
Objective response rates
Time to progression
Survival

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Colon Cancer
Colorectal Cancer
Rectal Cancer

Intervention ^ICMJE

Other: Dose delay or dose reduction
Drug: pegfilgrastim

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

252

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00094809

Responsible Party

Global Development Leader, Amgen Inc.

Study ID Numbers ^ICMJE

20020715

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP