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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Cancer Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABX-EGF

Drug

2.5 mg/kg by an infusion pump over one hour

Primary outcomes

Objective Tumor Response

Time frame: End of initial 6 week treatment period

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Clinical Trial of the Safety and Efficacy of ABX-EGF as Second Line Treatment for Advanced Non-Small Lung Cancer

Important dates

Study start: 2003
Primary completion: 2004
Study completion: 2004
First posted: Jan 19, 2005
Registry last updated: Oct 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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