Non-small Cell Lung Cancer Clinical Trial
Official title:
A Randomized Phase II Trial of Two Dose Schedules of Carboplatin/Paclitaxel/Cetuximab in Stage IIIB/IV Non-small Cell Lung Cancer
The purpose of the study is to determine if the combination of cetuximab, carboplatin and paclitaxel will shrink a specific type of lung cancer known as non-small cell lung cancer (NSCLC). The safety of this combination will also be evaluated.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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