Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | ABX-EGF as Second Line Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)
