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A Phase 2 Multicenter Single Arm Clinical Trial of ABX-EGF Monotherapy in Subjects With Metastatic Colorectal Cancer Whose Tumors Express Low or Negative EGFr Levels of Immunohistochemistry Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Metastases

Thank you

Trial Information

A Phase 2 Multicenter Single Arm Clinical Trial of ABX-EGF Monotherapy in Subjects With Metastatic Colorectal Cancer Whose Tumors Express Low or Negative EGFr Levels of Immunohistochemistry Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy


Inclusion Criteria:



- Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by
tissue biopsy)

- Metastatic colorectal carcinoma

- Eastern Cooperative Oncology Group of 0, 1 or 2

- Documented evidence of disease progression during, or following treatment, with
fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal
cancer

- Radiographic documentation of disease progression during or within 6 months following
the most recent chemotherapy regimen is required

- Bidimensionally measurable disease

- Tumor expressing low to negative levels of EGFr by immunohistochemistry

- At least 2 but no more than 3 prior chemotherapy regimens for metastatic colorectal
cancer

- Adequate hematologic, renal and hepatic function

Exclusion Criteria:

- Symptomatic brain metastases requiring treatment

- Patient with a history of interstitial pneumonitis or pulmonary fibrosis or evidence
of interstitial pneumonitis or pulmonary fibrosis

- Use of systemic chemotherapy or radiotherapy within 30 days before enrollment

- Prior anti-EGFr antibody therapy with the exception of the small molecule EGFr
tyrosine kinase inhibitors, which are permitted

- Prior anti-tumor therapies including prior experimental agents or approved anti-tumor
small molecules and biologics of short (less than 1 week) serum half-life within 30
days before enrollment, or prior experimental or approved proteins within 6 weeks
before enrollment

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20030250

NCT ID:

NCT00089635

Start Date:

August 2004

Completion Date:

December 2008

Related Keywords:

  • Colorectal Cancer
  • Metastases
  • Colon, Rectal Cancer
  • ABX-EGF, Panitumumab, EGFr
  • Immunex, Abgenix, Amgen
  • Metastatic Colorectal Cancer
  • Colorectal Neoplasms
  • Neoplasm Metastasis

Name

Location

Research Site Alabaster, Alabama  
Research Site Mesa, Arizona  
Research Site Bentonville, Arkansas  
Research Site Anaheim, California  
Research Site Boulder, Colorado  
Research Site Danbury, Connecticut  
Research Site Boca Raton, Florida  
Research Site Albany, Georgia  
Research Site Boise, Idaho  
Research Site Arlington Heights, Illinois  
Research Site Bloomington, Indiana  
Research Site Hays, Kansas  
Research Site Ashland, Kentucky  
Research Site Baltimore, Maryland  
Research Site Battle Kreek, Michigan  
Research Site Alexandria, Minnesota  
Research Site Branson, Missouri  
Research Site Billings, Montana  
Research Site Grand Island, Nebraska  
Research Site Las Vegas, Nevada  
Research Site Belleville, New Jersey  
Research Site Albuquerque, New Mexico  
Research Site Albany, New York  
Research Site Asheville, North Carolina  
Research Site Akron, Ohio  
Research Site Enid, Oklahoma  
Research Site Bend, Oregon  
Research Site Allentown, Pennsylvania  
Research Site Charleston, South Carolina  
Research Site Chattanooga, Tennessee  
Research Site Abilene, Texas  
Research Site Ivins, Utah  
Research Site Abington, Virginia  
Research Site Auburn, Washington  
Research Site Appleton, Wisconsin