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ABX-EGF as Second Line Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00101920
First received: January 18, 2005
Last updated: October 14, 2010
Last verified: October 2010
  Purpose

Rationale: Overexpression of epidermal growth factor receptor (EGFR) has been observed in kidney, prostate, colon, lung, breast, and other cancers, and is often associated with a poor prognosis. TGFa and EGF, the ligands for EGFR, are also overexpressed in some of these tumor types, suggesting a self-propagating stimulus that may be responsible for rapid tumor growth. Blocking this stimulus by blocking activation of EGFR with ABX-EGF, a fully human monoclonal antibody against EGFR, may prevent tumor growth and perhaps shrink tumors. Purpose: This is a Phase 2 clinical trial to evaluate the safety and efficacy of ABX-EGF in the treatment of advanced NSCLC following failure of paclitaxel and carboplatin therapy on treatment arm 1 of Immunex Protocol 054.0004 (Amgen Protocol 20025404), Part 2.


Condition Intervention Phase
Non-small Cell Lung Cancer
Neoplasm Metastasis
Lung Cancer
Drug: ABX-EGF
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Trial of the Safety and Efficacy of ABX-EGF as Second Line Treatment for Advanced Non-Small Lung Cancer

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Objective Tumor Response [ Time Frame: End of initial 6 week treatment period ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: June 2003
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABX-EGF
Open-label, single arm panitumamab monotherapy
Drug: ABX-EGF
2.5 mg/kg by an infusion pump over one hour

  Eligibility

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

Inclusion Criteria:

  • 18 years of age or older.
  • Diagnosis of NSCLC.
  • Unidimensionally measurable disease.
  • Documented disease progression within 6 months of the subject's last dose of carboplatin and paclitaxel in treatment arm 1, part 2 of Immunex Protocol 054.0004 (Amgen Protocol 20025404).
  • Disease stage IIIB with pericardial or pleural effusion, or stage IV.
  • Life expectancy of at least 12 weeks.
  • ANC greater than or equal to 1.5 x 10^9/L, platelet count greater than or equal to 100 x 10^9/L.
  • Adequate hematology function
  • Adequate renal function
  • Adequate hepatic function
  • ECOG score of less than 2.
  • Brain metastases, if present, must be controlled and asymptomatic.

Exclusion Criteria:

  • Calcium >ULN (treatment for hypercalcemia allowed).
  • Use of any investigational therapy within 30 days of ABX-EGF infusion.
  • Any cancer therapy for NSCLC other than paclitaxel and carboplatin per Immunex Protocol 054.0004 (Amgen Protocol 20025404), such as radiation therapy, surgery, or steroids.
  • Paclitaxel or carboplatin within 30 days before the first ABX-EGF infusion.
  • Radiation therapy within 2 weeks before ABX-EGF infusion.
  • LVEF less than 45% as measured by MUGA.
  • Symptomatic ventricular arrhythmia or symptomatic conduction abnormality.
  • Myocardial infarction within 1 year before first dose of study drug.
  • History of cancer that has required treatment or been active within past 5 years, other than NSCLC, basal cell carcinoma, or cervical carcinoma in situ.
  • Women (e.g., of childbearing potential, who are post-menopausal for less than six months, not surgically sterilized or not abstinent) who are not willing to use an oral or implanted contraceptive, double barrier birth control, or an IUD during the course of the study and for 6 months following treatment.
  • Men not willing to use contraception upon enrollment into this study and for 1 month following treatment.
  • Women who are breast-feeding or have a positive pregnancy test within 72 hours of first study drug administration.
  • Known to be HIV positive.
  • Any patient who's best medical interests would not be met by entry in the study in the opinion of the Investigators.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00101920

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

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00101920     History of Changes
Obsolete Identifiers: NCT00079209
Other Study ID Numbers: 20025408
Study First Received: January 18, 2005
Last Updated: October 14, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014