Status:
COMPLETED
ABX-EGF as Second Line Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)
Lead Sponsor:
Amgen
Conditions:
Non-small Cell Lung Cancer
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00101920
Start Date
June 1 2003
End Date
December 1 2004
Last Update
October 15 2010
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