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Evaluating ABX-EGF Plus Best Supportive Care Versus Best Supportive Care in Subjects withMetastatic Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00113763
First received: June 10, 2005
Last updated: July 1, 2010
Last verified: July 2010
History of Changes
  Purpose

The purpose of this study is to determine that ABX-EGF, using the proposed regimen, will safely increase progression free survival in subjects with metastatic colorectal cancer who have failed available treatment options (i.e., subjects who developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy.)


Condition Intervention Phase
Colorectal Cancer
Metastases
 Drug: ABX-EGF
Other: Best supportive care
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Phase 3 Clinical Trial of ABX-EGF Plus Best Supportive Care Versus Best Supportive Care in Subjects With Metastatic Colorectal Cancer

Resource links provided by NLM:

Drug Information available for: Panitumumab
U.S. FDA Resources

Further study details as provided by Amgen:

Enrollment: 463
Study Start Date: January 2004
Study Completion Date: June 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Panitumumab plus best supportive care
 Drug: ABX-EGF
IV infusion at a dose of 6 mg/kg once every 2 weeks.
Arm 2
Best supportive care alone
 Other: Best supportive care
Best supportive care as site routine excluding: antineoplastic chemotherapy, investigational agents, anti-EGFr targeting agents other than ABX-EGF, experimental or approved anti-tumor therapies (e.g. Avastin), chemotherapy, radiotherapy (with the exception of radiotherapy for pain control limited to bone metastases).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy)
  • Metastatic colorectal carcinoma
  • ECOG performance status 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
  • Unidimensionally measurable disease
  • Tumor expressing EGFr by immunohistochemistry
  • At least 2 but not more than 3 prior chemotherapy regimens for colorectal cancer
  • Adequate hematologic, renal and hepatic function

Exclusion Criteria:

  • Symptomatic brain metastases requiring treatment
  • History or evidence of interstitial pneumonitis or pulmonary fibrosis
  • Use of systemic chemotherapy or radiotherapy within 30 days prior to enrollment
  • Prior EGFr targeting therapies
  • Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than a week) serum half life within 30 days before enrollment, or prior experimental or approved proteins within 3 months before enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00113763

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00113763     History of Changes
Other Study ID Numbers: 20020408
Study First Received: June 10, 2005
Last Updated: July 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Metastatic Colorectal Cancer, Colon
Colorectal, Rectal Cancer, Cancer
Metastatic, EGFr, Clinical Trial
Panitumumab, ABX-EGF
Immunex, Abgenix, Amgen

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013