- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00101920
ABX-EGF as Second Line Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)
October 14, 2010 updated by: Amgen
A Clinical Trial of the Safety and Efficacy of ABX-EGF as Second Line Treatment for Advanced Non-Small Lung Cancer
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ABX-EGF
Open-label, single arm panitumamab monotherapy
|
2.5 mg/kg by an infusion pump over one hour
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective Tumor Response
Time Frame: End of initial 6 week treatment period
|
End of initial 6 week treatment period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Primary Completion (Actual)
December 1, 2004
Study Completion (Actual)
December 1, 2004
Study Registration Dates
First Submitted
January 18, 2005
First Submitted That Met QC Criteria
January 18, 2005
First Posted (Estimate)
January 19, 2005
Study Record Updates
Last Update Posted (Estimate)
October 15, 2010
Last Update Submitted That Met QC Criteria
October 14, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20025408
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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