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	Treatment or Intervention	Phase
Colon Cancer Colorectal Cancer Rectal Cancer	Drug: Neulasta®	Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Amgen Call Center      866-572-6436 

California
      Research Site, Vista,  California,  United States; Recruiting
Florida
      Research Site, Titusville,  Florida,  United States; Recruiting
Illinois
      Research Site, Centralia,  Illinois,  United States; Recruiting
Indiana
      Research Site, New Albany,  Indiana,  United States; Recruiting
      Research Site, Indianapolis,  Indiana,  United States; Recruiting
Maryland
      Research Site, Baltimore,  Maryland,  United States; Recruiting
Michigan
      Research Site, Riverview,  Michigan,  United States; Recruiting
Missouri
      Research Site, Rolla,  Missouri,  United States; Recruiting
      Research Site, Kansas City,  Missouri,  United States; Recruiting
Nevada
      Research Site, Henderson,  Nevada,  United States; Recruiting
New Hampshire
      Research Site, Portsmouth,  New Hampshire,  United States; Recruiting
Pennsylvania
      Research Site, Bethlehem,  Pennsylvania,  United States; Recruiting
      Research Site, Philadelphia,  Pennsylvania,  United States; Recruiting
      Research Site, Dunmore,  Pennsylvania,  United States; Recruiting
      Research Site, Scranton,  Pennsylvania,  United States; Recruiting
Tennessee
      Research Site, Chattanooga,  Tennessee,  United States; Recruiting
      Research Site, Collierville,  Tennessee,  United States; Recruiting
Virginia
      Research Site, Richland,  Virginia,  United States; Recruiting
Wisconsin
      Research Site, Rhinelander,  Wisconsin,  United States; Recruiting

Study ID Numbers:  20020715
Record last reviewed:  March 2005
Last Updated:  March 2, 2005
Record first received:  October 26, 2004
ClinicalTrials.gov Identifier:  NCT00094809
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08