This study is testing the investigational drug, cetuximab, in combination with different
chemotherapy drugs for lung cancer. The aim of the study is to determine which of the drug
combinations looks most promising and should be tested further. The study will also look at
what side effects may occur.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- Written informed consent before study-related activities
- Histologically or cytologically confirmed Stage IIIb with cytologically documented
malignant pleural or pericardial effusion, Stage IV, or recurrent non-smal cell lung
cancer (NSCLC) after resection or radiation for earlier stage disease
- Measurable or evaluable disease (per modified Response Evaluation Criteria in Solid
Tumors [RECIST] guidelines)
- Male or female ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- White blood count ≥ 3 x 10(9)/L with neutrophils ≥ 1. 5 x 10(9)/L, platelet count ≥
100 x 10(9)/L, and hemoglobin ≥ 9. 5 g/dL
- Total bilirubin ≤ 1. 5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2. 5 x ULN or ≤
5 x ULN in patients with liver mets
- Serum creatinine ≤ 1. 25 x ULN
- Recovery from prior surgery or radiation to Grade 1 or better toxicity
- Women of childbearing potential (WOCBP) and fertile men with partners of childbearing
potential must be using an adequate method of contraception to avoid pregnancy
throughout the study and for up to 4 wks after the study in such a manner that the
risk of pregnancy is minimized
- WOCBP must have a negative serum or urine pregnancy test within 72 hrs prior to the
start of study medication or in accordance with local regulations, whichever is of
shorter duration
Exclusion Criteria:
- WOCBP who are unwilling or unable to use an acceptable method of birth control to
avoid pregnancy for the entire study period and for up to 4 weeks after the study
- Women who are pregnant or breastfeeding
- Women with a positive pregnancy test during screening or prior to study drug
administration
- Sexually active fertile men not using effective birth control if their partners are
women of child-bearing potential
- Prior chemo for advanced NSCLC; neoadjuvant or post-operative adjuvant chemo is
allowed if completed at least 12 months before study entry
- Previous exposure to epidermal growth factor receptor (EGFR)-targeted therapy. Prior
treatment with monoclonal antibodies targeting receptors other than the EGFR, such as
bevacizumab, is allowed if completed > 30 days prior to randomization
- Treatment with any investigational agent(s) within 4 weeks prior to study entry
- Concurrent anti-cancer therapy (chemotherapy, hormonal therapy, biologic or targeted
therapy) other than protocol therapy
- Carcinoid, atypical carcinoid or small cell lung cancer
- Symptomatic or uncontrolled mets in the central nervous system
- Prior invasive malignancy requiring ongoing therapy within the past year
- Active infection (infection requiring intravenous [IV] antibiotics), including active
tuberculosis, known and declared HIV
- Myocardial infarction within 6 months prior to study entry, uncontrolled congestive
heart failure; or any current Grade 3 or 4 cardiovascular disorder despite treatment
- Known allergic/hypersensitivity reaction to any of the components of study treatments
- Peripheral neuropathy ≥ Grade 2, as assessed by Common Terminology Criteria for
Adverse Events, version 3. 0
- History of significant neurologic or psychiatric disorders including but not limited
to dementia, seizures, and bipolar disorder
- Medical or psychological condition that would not permit the patient to complete the
study or sign informed consent
- Known drug abuse
Patients of all races and ethnic groups are eligible for this trial.
Anniston, Alabama, United States
Jonesboro, Arkansas, United States
Anaheim, California, United States
Azusa, California, United States
Burbank, California, United States
Campbell, California, United States
Greenbrae, California, United States
Hawthorne, California, United States
Mission Hills, California, United States
Orange, California, United States
Oxnard, California, United States
St. Helena, California, United States
Fort Collins, Colorado, United States
Norwich, Connecticut, United States
Torrington, Connecticut, United States
Trumbull, Connecticut, United States
Fort Lauderdale, Florida, United States
Lake Worth, Florida, United States
Orange City, Florida, United States
Pembroke Pines, Florida, United States
St. Petersburg, Florida, United States
Titusville, Florida, United States
Weston, Florida, United States
Augusta, Georgia, United States
Columbus, Georgia, United States
Lawrenceville, Georgia, United States
Marietta, Georgia, United States
Valdosta, Georgia, United States
Elmhurst, Illinois, United States
Harvey, Illinois, United States
Joliet, Illinois, United States
Quincy, Illinois, United States
Skokie, Illinois, United States
South Bend, Indiana, United States
Family Medicine of Vincennes, Vincennes, Indiana, United States
Arnes, Iowa, United States
Bettendorf, Iowa, United States
Mason City, Iowa, United States
Waterloo, Iowa, United States
Hazard, Kentucky, United States
Louisville, Kentucky, United States
Lafayette, Louisiana, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Towson, Maryland, United States
Springfield, Massachusetts, United States
Worchester, Massachusetts, United States
Jefferson City, Missouri, United States
St. Joseph, Missouri, United States
St. Louis, Missouri, United States
Billings, Montana, United States
Grand Island, Nebraska, United States
Omaha, Nebraska, United States
Portsmouth, New Hampshire, United States
Bellville, New Jersey, United States
Cherry Hill, New Jersey, United States
Elizabeth, New Jersey, United States
Hackensack, New Jersey, United States
Bronx, New York, United States
East Setauket, New York, United States
Fresh Meadows, New York, United States
Fayetteville, North Carolina, United States
Gastonia, North Carolina, United States
Goldsboro, North Carolina, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Middletown, Ohio, United States
Sandusky, Ohio, United States
Bend, Oregon, United States
Bethlehem, Pennsylvania, United States
Reading, Pennsylvania, United States
Sumter, South Carolina, United States
Sioux Falls, South Dakota, United States
Bristol, Tennessee, United States
Chattanooga, Tennessee, United States
Memphis, Tennessee, United States
Beaumont, Texas, United States
Corpus Christi, Texas, United States
Lubbock, Texas, United States
Bennington, Vermont, United States
Kirkland, Washington, United States
Tacoma, Washington, United States
Huntington, West Virginia, United States
Wauwatosa, Wisconsin, United States