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

This study has been completed.

Study NCT00094809 Information provided by Amgen

First Received on October 26, 2004. Last Updated on May 13, 2011 History of Changes

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

Hide Participant Flow

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
Unknown	1	1

[1]	Subjects who completed treatment and Long term follow up (LTFU)
[2]	Subjects who completed treatment and LTFU

Baseline Characteristics

Hide Baseline Characteristics

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

Baseline Measures

	Pegfilgrastim (Neulasta)	Placebo	Total
Number of Participants [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

Show All Outcome Measures

1. Primary:

Grade 3 or 4 Neutropenia [ Time Frame: First 4 cycles of treatment (8 weeks) ]

Show Outcome Measure 1

2. Primary:

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

Show Outcome Measure 2

3. Secondary:

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

Show Outcome Measure 3

4. Secondary:

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

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

6. Secondary:

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

Show Outcome Measure 6

7. Secondary:

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

Show Outcome Measure 7

8. Secondary:

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

Show Outcome Measure 8

9. Secondary:

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

Show Outcome Measure 9

10. Secondary:

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

Show Outcome Measure 10

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.

Limitations and Caveats

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.

Results Point of Contact:

Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436

Publications of Results:

Hecht JR, Pillai M, Gollard R, Heim W, Swan F, Patel R, Dreiling L, Mo M, Malik I. A randomized, placebo-controlled phase ii study evaluating the reduction of neutropenia and febrile neutropenia in patients with colorectal cancer receiving pegfilgrastim with every-2-week chemotherapy. Clin Colorectal Cancer. 2010 Apr;9(2):95-101.

Responsible Party:	Global Development Leader, Amgen Inc.
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 13, 2011
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