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.
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.
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There is 1 Location for this study
Birmingham Alabama, , United States
Mobile Alabama, , United States
Anchorage Alaska, , United States
Tucson Arizona, , United States
Springdale Arkansas, , United States
Anaheim California, , United States
Bakersfield California, , United States
Concord California, , United States
Fountain Valley California, , United States
Gilroy California, , United States
Long Beach California, , United States
Los Angeles California, , United States
Montebello California, , United States
Oxnard California, , United States
Rancho Mirage California, , United States
San Diego California, , United States
Stockton California, , United States
Vista California, , United States
Lakewood Colorado, , United States
Binghamton Connecticut, , United States
Hartford Connecticut, , United States
New London Connecticut, , United States
Norwich Connecticut, , United States
Stamford Connecticut, , United States
Waterbury Connecticut, , United States
Washington District of Columbia, , United States
Boca Raton Florida, , United States
Boynton Beach Florida, , United States
Fort Lauderdale Florida, , United States
Fort Myers Florida, , United States
Inverness Florida, , United States
Jacksonville Florida, , United States
Lakeland Florida, , United States
Lecanto Florida, , United States
Pembroke Pines Florida, , United States
Port Saint Lucie Florida, , United States
Tamarac Florida, , United States
Tampa Florida, , United States
Augusta Georgia, , United States
Columbus Georgia, , United States
Marietta Georgia, , United States
Honolulu Hawaii, , United States
Evanston Illinois, , United States
Joliet Illinois, , United States
Naperville Illinois, , United States
Normal Illinois, , United States
Skokie Illinois, , United States
Fort Wayne Indiana, , United States
Muncie Indiana, , United States
New Albany Indiana, , United States
Terre Haute Indiana, , United States
Vincennes Indiana, , United States
Wichita Kansas, , United States
Hazard Kentucky, , United States
Paducah Kentucky, , United States
Annapolis Maryland, , United States
Baltimore Maryland, , United States
Westminster Maryland, , United States
Boston Massachusetts, , United States
Brockton Massachusetts, , United States
Flint Michigan, , United States
Free Soil Michigan, , United States
Grand Rapids Michigan, , United States
Jackson Michigan, , United States
Dulluth Minnesota, , United States
Minneapolis Minnesota, , United States
St. Louis Park Minnesota, , United States
Jackson Mississippi, , United States
Columbia Missouri, , United States
Jefferson City Missouri, , United States
Dover New Hampshire, , United States
Newark New Jersey, , United States
Bronx New York, , United States
Cooperstown New York, , United States
New City New York, , United States
New Rochelle New York, , United States
Northport New York, , United States
Rochester New York, , United States
Valhalla New York, , United States
Burlington North Carolina, , United States
Charlotte North Carolina, , United States
Gastonia North Carolina, , United States
Greensboro North Carolina, , United States
Greenville North Carolina, , United States
Hickory North Carolina, , United States
Morganton North Carolina, , United States
Wilmington North Carolina, , United States
Winston-Salem North Carolina, , United States
Bismarck North Dakota, , United States
Bismark North Dakota, , United States
Canton Ohio, , United States
Cincinnati Ohio, , United States
Cleveland Ohio, , United States
Columbus Ohio, , United States
Dayton Ohio, , United States
Oklahoma City Oklahoma, , United States
Bethlehem Pennsylvania, , United States
Dunmore Pennsylvania, , United States
Harrisburg Pennsylvania, , United States
Philadelphia Pennsylvania, , United States
Pottstown Pennsylvania, , United States
Sayre Pennsylvania, , United States
West Reading Pennsylvania, , United States
Providence Rhode Island, , United States
Charleston South Carolina, , United States
Columbia South Carolina, , United States
Mt. Pleasant South Carolina, , United States
Spartanburg South Carolina, , United States
Sumter South Carolina, , United States
Chattanooga Tennessee, , United States
Collierville Tennessee, , United States
Cookeville Tennessee, , United States
Amarillo Texas, , United States
Dallas Texas, , United States
Houston Texas, , United States
Lubbock Texas, , United States
Danville Virginia, , United States
Lynchburg Virginia, , United States
Richmond Virginia, , United States
Everett Washington, , United States
Lacey Washington, , United States
Tacoma Washington, , United States
Huntington West Virginia, , United States
La Crosse Wisconsin, , United States
Madison Wisconsin, , United States
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