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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 SiteAlabaster, Alabama  
Research SiteMesa, Arizona  
Research SiteBentonville, Arkansas  
Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteDanbury, Connecticut  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteBoise, Idaho  
Research SiteArlington Heights, Illinois  
Research SiteBloomington, Indiana  
Research SiteHays, Kansas  
Research SiteAshland, Kentucky  
Research SiteBaltimore, Maryland  
Research SiteBattle Kreek, Michigan  
Research SiteAlexandria, Minnesota  
Research SiteBranson, Missouri  
Research SiteBillings, Montana  
Research SiteGrand Island, Nebraska  
Research SiteLas Vegas, Nevada  
Research SiteBelleville, New Jersey  
Research SiteAlbuquerque, New Mexico  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteAkron, Ohio  
Research SiteEnid, Oklahoma  
Research SiteBend, Oregon  
Research SiteAllentown, Pennsylvania  
Research SiteCharleston, South Carolina  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteIvins, Utah  
Research SiteAbington, Virginia  
Research SiteAuburn, Washington  
Research SiteAppleton, Wisconsin