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 combination with paclitaxel and carboplatin in the treatment of advanced NSCLC.

Condition	Treatment or Intervention	Phase
Carcinoma, Non-Small-Cell Lung Neoplasm Neoplasm Metastasis Lung Cancer	Drug: ABX-EGF  Drug: paclitaxel  Drug: carboplatin	Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA:

• 18 years of age or older.
• Female patients who are post-menopausal, surgically sterilized, or of childbearing potential using acceptable birth control and have a negative serum pregnancy test upon study entry; or male patients willing to use contraception upon study enrollment.
• Diagnosis of NSCLC.
• Bidimensionally measurable disease.
• Tumor tissue available for immunohistochemistry studies.
• Tumor over-expressing EGFR as ascertained by immunohistochemistry.
• 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 109/L, platelet count greater than or equal to 100 x 109/L.
• Creatinine clearance greater than 15 mL/min.
• Alkaline phosphatase less than or equal to 3x ULN, AST less than or equal to 3 x ULN, ALT less than or equal to 3 x ULN, bilirubin less than or equal to 1.5 ULN.
• ECOG score of less than 2.
• Brain metastases, if present, must be controlled and asymptomatic.

EXCLUSION CRITERIA:

• Calcium greater than or equal to 11.6 mg/dL (treatment for hypercalcemia allowed).
• Use of any investigational therapy within 30 days of ABX-EGF infusion.
• Any cancer therapy for NSCLC other than radiation therapy, surgery, or steroids.
• 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.
• 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.

Texas
      Research Site, San Antonio,  Texas,  United States

Study ID Numbers:  054.0004
Record last reviewed:  July 2004
Record first received:  April 25, 2002
ClinicalTrials.gov Identifier:  NCT00034346
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-25