Spots Global Cancer Trial Database for Trial of Carboplatin/Paclitaxel/Cetuximab in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)

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Trial Identification

Brief Title: Trial of Carboplatin/Paclitaxel/Cetuximab in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)

Official Title: A Randomized Phase II Trial of Two Dose Schedules of Carboplatin/Paclitaxel/Cetuximab in Stage IIIB/IV Non-small Cell Lung Cancer

Study ID: NCT00097227

Conditions

Non-small Cell Lung Cancer

Interventions

Cetuximab

Carboplatin

Paclitaxel

Study Description

Brief Summary: 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.

Detailed Description: 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.