A Randomized Phase II Trial of Two Dose Schedules of Carboplatin/Paclitaxel/Cetuximab in Stage IIIB/IV Non-small Cell Lung Cancer
Lung cancer is the second most common cancer diagnosed for both genders in the United
States. Approximately 173,770 new cases are estimated for 2004. It is the leading cause of
cancer deaths in both men and women, with approximately 160,440 deaths estimated for 2004.
Prognosis for many is poor if not diagnosed at an early stage, and therapy for advanced
disease is limited. The study will test two chemotherapy agents, carboplatin and
paclitaxel, in combination with a newly approved drug called cetuximab, which is continuing
to be tested in colorectal cancer and other cancers. Cetuximab is a monoclonal antibody,
which is believed to work by attaching to an epidermal growth factor receptor (EGFR) on
tumor cells and thereby blocking tumor cells from reproducing. It is an antibody to the
EGFR. Fifty percent of lung cancers overexpress EGFR.
Rationale:
The present study is built upon the data from previous studies, incorporating cetuximab into
each of two regimens of paclitaxel plus carboplatin. The results of prior studies using
paclitaxel and carboplatin demonstrate that these drugs in combination, using a variety of
schedules, are both safe and effective as therapy for advanced or metastatic NSCLC. The
addition of biologic therapy with the anti-EGFR agent cetuximab to the combination will
presumably maximize the therapeutic index while keeping toxicity to a minimum in patients
with Stage IIIB/IV NSCLC.
Research Hypothesis:
Subjects with previously-untreated stage IIIB/IV NSCLC who receive a combination of
paclitaxel, carboplatin, and cetuximab will have a progression-free survival rate greater
than that previously reported for subjects receiving the combination of paclitaxel and
carboplatin.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To estimate median progression free survival and the progression free survival rate
6 months
No
E-mail: ClinicalTrials@ ImClone.com
Study Chair
ImClone LLC
United States: Food and Drug Administration
CA225-058
NCT00097227
November 2004
April 2007
Name | Location |
---|---|
ImClone Investigational Site | Indianapolis, Indiana 46202 |
ImClone Investigational Site | Bakersfield, California 93309 |
ImClone Investigational Site | Jacksonville, Florida 32207 |
ImClone Investigational Site | Atlanta, Georgia 30318 |
ImClone Investigational Site | Louisville, Kentucky 40202 |
ImClone Investigational Site | Baltimore, Maryland 21204 |
ImClone Investigational Site | Ypsilanti, Michigan 48198 |
ImClone Investigational Site | Voorhees, New Jersey 08043 |
ImClone Investigational Site | Greenville, South Carolina 29605 |
ImClone Investigational Site | Memphis, Tennessee 38104 |
ImClone Investigational Site | Dallas, Texas 75230 |
ImClone Investigational Site | Norfolk, Virginia 23502 |
ImClone Investigational Site | Winston-Salem, North Carolina 27103 |
ImClone Investigational Site | Philadelphia, Pennsylvania 19107 |
ImClone Investigational Site | Seattle, Washington 98104 |
ImClone Investigational Site | Newark, Delaware 19713 |
ImClone Investigational Site | Morgantown, West Virginia 26506 |