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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
165
(Week 1) of 400 mg/m2 IV infusion and a weekly maintenance dose of 250 mg/m2 IV infusion. A cycle of therapy was defined as 3 weeks in Arm A and 4 weeks in Arm B.
(AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 3 weeks (AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 4 weeks.
225 mg/m2 infused over 180 minutes on Day 1 and subsequently every 3 weeks. OR 100 mg/m2 infused over 180 minutes on Day 1, Day 8 and Day 15 of a 4-week cycle.
ImClone Investigational Site
Los Angeles, California, United States
ImClone Investigational Site
To estimate median progression free survival and the progression free survival rate
Time frame: 6 months
To estimate the overall response rate in each treatment arm
Time frame: 6 months
To estimate median survival and the survival rate at one year in each treatment arm
Time frame: 6 months
To evaluate the toxicity profile of each treatment arm
Time frame: 6 months
To explore the relationship between EGFR expression and the "clinical benefit" received from each treatment regimen
Time frame: 6 months
To evaluate symptom response rate in each treatment arm using the Lung Cancer Subscale (LCS) of the FACT-L
Time frame: 6 months
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Santa Monica, California, United States
ImClone Investigational Site
Newark, Delaware, United States
ImClone Investigational Site
Orlando, Florida, United States
ImClone Investigational Site
St. Petersburg, Florida, United States
ImClone Investigational Site
Tucker, Georgia, United States
ImClone Investigational Site
Terra Haute, Indiana, United States
ImClone Investigational Site
Louisville, Kentucky, United States
ImClone Investigational Site
Baltimore, Maryland, United States
ImClone Investigational Site
Ypsilanti, Michigan, United States
...and 10 more locations