Neoadjuvant, Tarceva, Surgery for Non-Small Cell Lung Cancer (NSCLC)
The goal of this clinical research study is to learn if chemotherapy (cisplatin, docetaxel) is safe to give to patients whose lung cancer will be surgically removed, and to learn if maintenance therapy with the biologic agent erlotinib, given after surgery, is safe. Another goal of this study is to look at changes that occur in epidermal growth factor receptor (EGFR) and how these changes are reflected in different cells in the body. The effect of this treatment on the participant's quality of life and survival, as well as its effect on different cells in the body, will also be studied.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Neoadjuvant Chemotherapy With Docetaxel, Cisplatin Followed by Maintenance Therapy With the EGFR Inhibitor Erlotinib (Tarceva) in Patients With Stage I, II and III Non-Small Cell Lung Cancer Following Definitive Surgical Resection|
- Changes that occur in epidermal growth factor receptor (EGFR) and how these changes are reflected in different cells. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
- Safety of chemotherapy (cisplatin, docetaxel) given to patients whose lung cancer will be surgically removed, and erlotinib maintenance therapy given after surgery. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2005|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: Erlotinib + Cisplatin + Docetaxel
Erlotinib 150 mg by mouth daily for 1 year. Cisplatin 80 mg/m^2 IV over a 30 minutes - 1 hour infusion every 3 weeks (21 day cycle) for 3 cycles before surgery. Docetaxel 75 mg/m^2 IV over a 1 hour infusion every 3 weeks (21 day cycle) for 3 cycles before surgery.
150 mg by mouth daily for 1 year.
Other Names:Drug: Cisplatin
80 mg/m^2 IV over a 30 minutes - 1 hour infusion every 3 weeks (21 day cycle) for 3 cycles before surgery.
Other Names:Drug: Docetaxel
75 mg/m^2 IV over a 1 hour infusion every 3 weeks (21 day cycle) for 3 cycles before surgery.
Other Name: Taxotere
Erlotinib (Tarcevaâ, OSI-774) is a drug that helps to block the activity of an enzyme that is believed to play an important role in cell growth. It is hoped that blocking these enzymes will slow tumor growth. Both cisplatin and docetaxel (Taxotereâ) are commonly used chemotherapy drugs. These drugs are designed to target and destroy cancer cells.
If you are found to be eligible, you will begin receiving chemotherapy with cisplatin and docetaxel. Cisplatin and docetaxel will be given by vein once every 3 weeks. Both will be given on the same day every 3 weeks. Docetaxel is given first over 1 hour. Cisplatin is given second over 30 minutes to 1 hour. You will receive three 3-week cycles of chemotherapy while on this study. Treatment with erlotinib will begin after you have had surgery to remove the lung cancer. You will take erlotinib by mouth every day for the remainder of your treatment on this study.
While taking chemotherapy, you will have blood tests every 3 weeks to look at your blood counts. This is to ensure that your body has recovered from the chemotherapy enough to continue treatment. About 2 teaspoons of blood will be needed for each test. These samples will be used only for routine lab tests. You will be seen by a physician every 3 weeks. At these visits, you will have a physical exam and a chest x-ray. You may have a neurological exam if your doctor thinks it is necessary. This exam will look at whether you have any numbness, test your hearing and vision, and will include other standard evaluations. Your vital signs and weight will be monitored and you will be asked about certain side effects. If necessary, depending on your side effects, you may need to have more frequent visits to see your physician.
After 3 cycles of chemotherapy (9 weeks), you will have a CT scan of the chest and abdominal area, and possibly a CT scan of the area where the disease may be coming back. These are done to check the status of the disease.
Within 90 days after surgery, you will begin taking erlotinib. On Day 1 of erlotinib treatment, you will have a physical exam, a performance status evaluation (questions about your ability to perform everyday activities), a chest x-ray, and blood drawn (about 2 teaspoons) for routine tests. These tests will be repeated at Month 2, Month 3, then every 3 months after that.
On Day 1 of erlotinib treatment and every 3 months after that, you will also have a CT scan of the chest and abdominal area, and possibly a CT scan of the area where the disease may be coming back.
You may receive treatment in the study for up to 1 year (3 cycles of cisplatin/docetaxel and then daily erlotinib for up to 1 year) and will receive long-term follow-up (for 5 years total) with your physician to monitor your condition and disease status. Your doctor may decide to take you off this study if you experience significant side effects or your medical condition worsens. Follow-up visits will include a chest x-ray and CT scan every 3 months during Year 2 and then every 6 months until Year 5.
This is an investigational study. Erlotinib is approved by the FDA for treatment of non-small cell lung cancer. Its use in this study is experimental. Docetaxel and cisplatin are FDA approved and commercially available. A total of 50 patients will take part in this study. All will be enrolled at MD Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254384
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||William N. William Jr., MD||M.D. Anderson Cancer Center|