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Evaluating ABX-EGF Monotherapy in Subjects With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy
This study is ongoing, but not recruiting participants.
First Received: May 26, 2004   Last Updated: November 19, 2009   History of Changes
Sponsor: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00083616
  Purpose

The purpose of this study is to determine that ABX-EGF will have clinically meaningful anti-tumor activity in patients with metastatic colorectal cancer who have developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy.


Condition Intervention Phase
Colorectal Cancer
Metastatic Cancer
Drug: ABX-EGF
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title: A Phase 2 Multicenter Single Arm Clinical Trial of ABX-EGF Monotherapy in Subjects With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Confirmed objective response through week 16 [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Confirmed objective response throughout study [ Designated as safety issue: No ]
  • Time to response [ Designated as safety issue: No ]
  • Progression-free survival time [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Duration of stable disease [ Designated as safety issue: No ]
  • Survival time [ Designated as safety issue: No ]
  • Change in patient-reported outcomes [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: No ]

Estimated Enrollment: 185
Study Start Date: March 2004
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Open label, single arm: Experimental
Panitumumab 6 mg/kg every 2 weeks
Drug: ABX-EGF
Panitumumab 6 mg/kg every 2 weeks

  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 - 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 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 epidermal growth factor receptor targeting agents - 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 with longer serum half-life (e.g., AvastinTM) within 6 weeks before enrollment

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00083616

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

Additional Information:
No publications provided

Responsible Party: Amgen Inc. ( Global Development Leader )
Study ID Numbers: 20030167
Study First Received: May 26, 2004
Last Updated: November 19, 2009
ClinicalTrials.gov Identifier: NCT00083616     History of Changes
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Irinotecan
Colonic Diseases
Enzyme Inhibitors
Intestinal Diseases
Rectal Diseases
Pharmacologic Actions
Intestinal Neoplasms
Oxaliplatin
Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Neoplasm Metastasis
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 25, 2009