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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00101920
Recruitment Status : Completed
First Posted : January 19, 2005
Last Update Posted : October 15, 2010
Sponsor:
Information provided by:
Amgen

Tracking Information
First Submitted Date  ICMJE January 18, 2005
First Posted Date  ICMJE January 19, 2005
Last Update Posted Date October 15, 2010
Study Start Date  ICMJE June 2003
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2010)
Objective Tumor Response [ Time Frame: End of initial 6 week treatment period ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ABX-EGF as Second Line Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)
Official Title  ICMJE A Clinical Trial of the Safety and Efficacy of ABX-EGF as Second Line Treatment for Advanced Non-Small Lung Cancer
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-small Cell Lung Cancer
  • Neoplasm Metastasis
  • Lung Cancer
Intervention  ICMJE Drug: ABX-EGF
2.5 mg/kg by an infusion pump over one hour
Study Arms  ICMJE Experimental: ABX-EGF
Open-label, single arm panitumamab monotherapy
Intervention: Drug: ABX-EGF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2007)
50
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2004
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00101920
Other Study ID Numbers  ICMJE 20025408
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Global Development Leader, Amgen Inc.
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Amgen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP