Lung Cancer Clinical Trial

Study of Taxane/Carboplatin +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

Summary

The primary purpose of this clinical research study is to learn if patients treated with the combination of Taxane/Carboplatin plus Cetuximab (C/T/C) have a longer progression-free survival than patients treated with Taxane/Carboplatin (T/C) alone. The safety of this treatment will also be studied.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy.
Tumor/disease lesions that can be measured bidimensionally.
Must be able to carry-out work of light or sedentary nature (e.g. light house work, office work).
Adequate recovery from recent surgery or radiation therapy.
Must be at least 4 weeks from last major surgery or prior treatment with an investigational agent. At least 12 weeks from any radiation therapy to chest.
Accessible for treatment, follow-up and required visits at a participating center(s).

Exclusion Criteria:

Prior chemotherapy or adjuvant chemotherapy for the treatment of lung cancer.
Prior treatment with cetuximab or other epidermal growth factor (EGFR)-targeted therapy.
Prior severe infusion reaction to antibody therapy.
Concurrent malignancy (previous malignancy without evidence of disease for 5 years will be allowed to enter trial).
Concurrent chemotherapy or therapy with another investigational agent not indicated in the protocol.
Serious uncontrolled medical disorders that would impair the ability to receive therapy.
History of myocardial infarction within prior 3 months, uncontrolled angina, uncontrolled arrhythmia, or uncontrolled congestive heart failure.
Symptomatic or uncontrolled metastases in the central nervous system. Subjects receiving a glucocorticoid for central nervous system (CNS) metastases are not eligible, but those receiving an anticonvulsant are eligible.
Peripheral neuropathy >= grade 2 (Common Toxicity Criteria Adverse Event [CTCAE] Version 3.0).
Inadequate hematologic and/or liver and/or kidney function.
Sexually active and fertile individuals or partners of these individuals who are unwilling or unable to use an acceptable method of birth control for entire trial and up to 4 weeks after the study.
Women who are pregnant or breastfeeding.
Women with a positive pregnancy test on enrollment prior to study drug administration.
Altered mental status or psychiatric condition that prohibits understanding or rendering of consent.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

755

Study ID:

NCT00112294

Recruitment Status:

Completed

Sponsor:

Eli Lilly and Company

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There is 1 Location for this study

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Birmingham Alabama, , United States
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Mobile Alabama, , United States
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Anchorage Alaska, , United States
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Tucson Arizona, , United States
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Springdale Arkansas, , United States
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Anaheim California, , United States
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Bakersfield California, , United States
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Concord California, , United States
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Fountain Valley California, , United States
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Gilroy California, , United States
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Long Beach California, , United States
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Los Angeles California, , United States
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Montebello California, , United States
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Oxnard California, , United States
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Rancho Mirage California, , United States
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San Diego California, , United States
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Stockton California, , United States
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Vista California, , United States
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Lakewood Colorado, , United States
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Binghamton Connecticut, , United States
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Hartford Connecticut, , United States
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New London Connecticut, , United States
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Norwich Connecticut, , United States
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Stamford Connecticut, , United States
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Waterbury Connecticut, , United States
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Washington District of Columbia, , United States
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Boca Raton Florida, , United States
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Boynton Beach Florida, , United States
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Fort Lauderdale Florida, , United States
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Fort Myers Florida, , United States
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Inverness Florida, , United States
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Jacksonville Florida, , United States
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Lakeland Florida, , United States
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Lecanto Florida, , United States
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Pembroke Pines Florida, , United States
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Port Saint Lucie Florida, , United States
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Tamarac Florida, , United States
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Tampa Florida, , United States
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Augusta Georgia, , United States
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Columbus Georgia, , United States
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Marietta Georgia, , United States
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Honolulu Hawaii, , United States
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Evanston Illinois, , United States
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Joliet Illinois, , United States
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Naperville Illinois, , United States
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Normal Illinois, , United States
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Skokie Illinois, , United States
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Fort Wayne Indiana, , United States
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Muncie Indiana, , United States
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New Albany Indiana, , United States
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Terre Haute Indiana, , United States
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Vincennes Indiana, , United States
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Wichita Kansas, , United States
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Hazard Kentucky, , United States
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Paducah Kentucky, , United States
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Annapolis Maryland, , United States
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Baltimore Maryland, , United States
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Westminster Maryland, , United States
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Boston Massachusetts, , United States
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Brockton Massachusetts, , United States
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Flint Michigan, , United States
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Free Soil Michigan, , United States
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Grand Rapids Michigan, , United States
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Jackson Michigan, , United States
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Dulluth Minnesota, , United States
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Minneapolis Minnesota, , United States
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St. Louis Park Minnesota, , United States
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Jackson Mississippi, , United States
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Columbia Missouri, , United States
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Jefferson City Missouri, , United States
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Dover New Hampshire, , United States
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Newark New Jersey, , United States
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Bronx New York, , United States
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Cooperstown New York, , United States
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New City New York, , United States
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New Rochelle New York, , United States
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Northport New York, , United States
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Rochester New York, , United States
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Valhalla New York, , United States
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Burlington North Carolina, , United States
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Charlotte North Carolina, , United States
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Gastonia North Carolina, , United States
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Greensboro North Carolina, , United States
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Greenville North Carolina, , United States
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Hickory North Carolina, , United States
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Morganton North Carolina, , United States
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Wilmington North Carolina, , United States
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Winston-Salem North Carolina, , United States
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Bismarck North Dakota, , United States
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Bismark North Dakota, , United States
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Canton Ohio, , United States
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Cincinnati Ohio, , United States
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Cleveland Ohio, , United States
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Columbus Ohio, , United States
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Dayton Ohio, , United States
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Oklahoma City Oklahoma, , United States
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Bethlehem Pennsylvania, , United States
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Dunmore Pennsylvania, , United States
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Harrisburg Pennsylvania, , United States
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Philadelphia Pennsylvania, , United States
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Pottstown Pennsylvania, , United States
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Sayre Pennsylvania, , United States
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West Reading Pennsylvania, , United States
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Providence Rhode Island, , United States
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Charleston South Carolina, , United States
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Columbia South Carolina, , United States
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Mt. Pleasant South Carolina, , United States
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Spartanburg South Carolina, , United States
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Sumter South Carolina, , United States
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Chattanooga Tennessee, , United States
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Collierville Tennessee, , United States
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Cookeville Tennessee, , United States
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Amarillo Texas, , United States
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Dallas Texas, , United States
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Houston Texas, , United States
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Lubbock Texas, , United States
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Danville Virginia, , United States
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Lynchburg Virginia, , United States
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Richmond Virginia, , United States
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Everett Washington, , United States
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Lacey Washington, , United States
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Tacoma Washington, , United States
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Huntington West Virginia, , United States
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La Crosse Wisconsin, , United States
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Madison Wisconsin, , United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

755

Study ID:

NCT00112294

Recruitment Status:

Completed

Sponsor:


Eli Lilly and Company

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