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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer, Neoplasm Metastasis, Lung Cancer

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Trial Information

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

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Disease Progression

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20025404

NCT ID:

NCT00034346

Start Date:

January 2002

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Neoplasm Metastasis
  • Lung Cancer
  • Advanced
  • Non-Small-Cell
  • Lung
  • Cancer
  • NSCLC
  • Carcinoma
  • Advanced Non-Small-Cell Lung Cancer (NSCLC)
  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis

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