Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Chemotherapy Administered Every 2 Weeks With or Without Pegfilgrastim in Subjects With Advanced or Metastatic Colon Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00094809
First received: October 26, 2004
Last updated: May 10, 2013
Last verified: May 2013
Results First Received: December 16, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Supportive Care
Conditions: Colon Cancer
Colorectal Cancer
Rectal Cancer
Interventions: Drug: Placebo
Drug: Pegfilgrastim

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from 12 February 2003 through 13 January 2006

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pegfilgrastim (Neulasta) Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
Placebo Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion

Participant Flow:   Overall Study
    Pegfilgrastim (Neulasta)   Placebo
STARTED   126   126 
Received Study Drug   124   118 
Properly Consented; Received Study Drug   123   118 
Completed All 4 Cycles of Treatment   98   90 
COMPLETED   74 [1]   61 [2] 
NOT COMPLETED   52   65 
Protocol deviation                2                2 
Noncompliance                1                0 
Adverse Event                3                1 
Withdrawal by Subject                8                9 
Disease progression                3                3 
Physician Decision                3                5 
Lost to Follow-up                6                6 
Death                19                25 
Protocol-specified criteria                1                1 
Other                2                4 
Informed consent signed after treatment                1                0 
Study drug not received                2                8 
Other                1                1 
[1] Subjects who completed treatment and Long term follow up (LTFU)
[2] Subjects who completed treatment and LTFU



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pegfilgrastim (Neulasta) Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
Placebo Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
Total Total of all reporting groups

Baseline Measures
   Pegfilgrastim (Neulasta)   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 123   118   241 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.4  (12.26)   62.9  (13.21)   62.7  (12.71) 
Gender 
[Units: Participants]
     
Female   45   34   79 
Male   78   84   162 
Race/Ethnicity, Customized 
[Units: Participants]
     
White or Caucasian   103   84   187 
Black or African American   12   12   24 
Hispanic or Latino   3   16   19 
Asian   3   3   6 
Japanese   1   0   1 
Native Hawaiian or Other Pacific Islander   0   3   3 
Other   1   0   1 
Chemotherapy Regimen [1] 
[Units: Participants]
     
FOIL   30   30   60 
FOLFOX   61   58   119 
FOLFIRI   32   30   62 
[1] FOIL = 5-fluorouracil, oxaliplatin, irinotecan, and leucovorin; FOLFOX = 5-fluorouracil, oxaliplatin, and leucovorin; FOLFIRI = 5-fluorouracil, irinotecan, and leucovorin


  Outcome Measures
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1.  Primary:   Grade 3 or 4 Neutropenia   [ Time Frame: First 4 cycles of treatment (8 weeks) ]

2.  Primary:   Grade 4 Neutropenia   [ Time Frame: First 4 cycles of treatment (8 weeks) ]

3.  Secondary:   Dose Delay or Reduction Due to Neutropenia   [ Time Frame: First 4 cycles of treatment (8 weeks) ]

4.  Secondary:   Dose Delay or Reduction for Any Reason   [ Time Frame: First 4 cycles of treatment (8 weeks) ]

5.  Secondary:   Febrile Neutropenia   [ Time Frame: First 4 cycles of treatment (8 weeks) ]

6.  Secondary:   Hospitalization Due to a Neutropenia-Related Event   [ Time Frame: First 4 cycles of neutropenia (8 weeks) ]

7.  Secondary:   Progression-Free Survival   [ Time Frame: Up to 24 months after first four cycles of treatment ]

8.  Secondary:   Objective Tumor Response   [ Time Frame: First 4 cycles of treatment (8 weeks) ]

9.  Secondary:   Survival   [ Time Frame: Up to 24 months after first four cycles of treatment ]

10.  Secondary:   Antibiotic Use Due to Febrile Neutropenia   [ Time Frame: First 4 cycles of treatment (8 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00094809     History of Changes
Obsolete Identifiers: NCT00119327
Other Study ID Numbers: 20020715
Study First Received: October 26, 2004
Results First Received: December 16, 2010
Last Updated: May 10, 2013
Health Authority: United States: Quorom Institutional Review Board
United States: Western Institutional Review Board
United States: Food and Drug Administration
United States: Institutional Review Board