ABX-EGF in Combination With Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)

Study Overview
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Brief Summary
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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.

Official Title
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A Two Part, Multiple Dose Clinical Trial of the Safety and Efficacy of ABX-EGF in Combination With Paclitaxel and Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer

Conditions
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Non-Small Cell Lung Cancer, Neoplasm Metastasis, Lung Cancer

Intervention / Treatment
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* Drug: ABX-EGF
* Drug: paclitaxel
* Drug: carboplatin


Participation Criteria
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Eligibility Criteria
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For complete inclusion and exclusion criteria, please refer to the investigator. Inclusion Criteria: - 18 years of age or older. - Pathological 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. - 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 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. - 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ABX-EGF|nan|
|Drug: paclitaxel|nan|
|Drug: carboplatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Disease Progression |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Overall Response Rate |  |  | 
| Response Rate at Week 5 |  |  | 
| Survival Time |  |  | 
| Progression Free Survival |  |  | 
| Rate of Progressive Disease at Week 11 |  |  | 
| Incidence of AEs |  |  | 
| Lab Abnormalities and other Safety Parameters |  |  | 
| PK of Panitumumab in Combination with Carboplatin and Paclitaxel |  |  | 
| Quality of Life |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced, Non-Small-Cell, Lung, Cancer, NSCLC, Carcinoma, Advanced Non-Small-Cell Lung Cancer (NSCLC)