TARCEVA (Erlotinib) in Combination With Chemoradiation in Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)
The goal of this clinical research study is to find out if erlotinib given with chemotherapy and radiation therapy can help to control Non-Small Cell Lung Cancer (NSCLC). The safety of this combination treatment will also be studied.
Researchers will also test the tissue from your earlier biopsy to measure the levels of epidermal growth factor receptor (EGFR). The purpose of EGFR testing is to learn about any link between various forms of EGFR and your response to treatment with erlotinib.
Determine the feasibility of concurrent erlotinib and chemoradiation as measured by safety and compliance. Safety is measured by the rate of grade 3 or worse nonhematological toxicities occurring prior to the beginning of consolidation therapy (including all toxicities attributed to chemoradiation occurring within 90 days of the start of radiation therapy); compliance is defined as the completion of the treatment regimen with no more than minor variations.
- Investigate associations between EGFR expression and toxicity, response, overall survival, and progression
- Estimate overall survival of patients on the study regimen (one and two year rates, median survival).
- Estimate the time to disease progression of patients on the study regimen (one and two year rates)
- Estimate the treatment response rate of patients on the study regimen (complete and partial response rates)
Non-Small Cell Lung Cancer
Radiation: Radiation Therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of TARCEVA (Erlotinib) in Combination With Chemoradiation in Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)|
- Time to Disease Progression [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]Time measured in months from treatment to disease progression, follow up every 6 months.
|Study Start Date:||November 2007|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: Erlotinib + Paclitaxel + Carboplatin
Oral Erlotinib 150 mg daily + Paclitaxel 45 mg/m^2 by vein weekly + Carboplatin 2 AUC by vein weekly and Radiation Therapy 63 GY/35 fractions for 7 weeks cycles
150 mg by mouth daily for 7 Weeks
Other Names:Drug: Carboplatin
2 AUC by vein weekly for 7 Weeks
Other Name: ParaplatinDrug: Paclitaxel
45 mg/m^2 by vein weekly for 7 Weeks
Other Name: TaxolRadiation: Radiation Therapy
63 GY/35 fractions for 7 weeks (+/- 5 days)
Erlotinib is designed to block the activity of a protein called epidermal growth factor (EGFR). EGFR is found on the surface of many tumor cells that may control tumor growth and survival. This may stop tumors from growing.
If you are found to be eligible to take part in this study, you will take erlotinib every day for 7 weeks (except on the days you receive chemotherapy). The erlotinib tablets should be taken at the same time each day, at least 1 hour before or 2 hours after a meal, with a small glass (about 7 ounces) of water. If you are unable to swallow tablets, you may dissolve the tablets in distilled water to drink.
You will receive radiation every day (Monday through Friday) for 7 weeks. You will also receive chemotherapy through a needle in a vein once a week for 7 weeks. The chemotherapy will include carboplatin and paclitaxel. Receiving chemotherapy will take about 6 hours total.
You will receive consolidation therapy on weeks 11-17.
Treatment on this study will last 17 weeks. Once a week during that time, you will have blood (about 2 tablespoons) drawn for routine tests. You will also have a CT scan of the chest within about 4 weeks from beginning the study, 2 months after finishing therapy, and then every 6 months after that for 2 years. The CT scans are used to check the status of the disease.
You will be taken off study if the disease gets worse or intolerable side effects occur. In this case, you would not receive erlotinib anymore but would continue standard chemotherapy and radiation therapy.
You will be asked to come in to the clinic for follow-up visits to check on your recovery from treatment. The follow-up visits will be at the end of all treatment, 1 month after treatment, and then once a month for as long as your doctor feels it is necessary. Once your side effects have become less severe, you will be asked to come in to the clinic for follow-up visits every 3 months for 2 years, and then every 4 months for the following 2 years after that. You will have a physical exam, and your medical history will be recorded. You will be asked about any side effects you may have. Blood (about 2 tablespoons) will be drawn for routine tests. You will have a PET scan.
You have the right to leave the study at any time. If you choose to stop participating in this study, you should contact the study chair and/or research nurse. Your doctor may decide to take you off this study if your medical condition gets worse and/or you are unable to comply with study requirements.
At the end of the study you will not be automatically notified of the research findings. If you wish to learn about the results, however, you may request them from the study chair.
This is an investigational study. All three study drugs are commercially available. Carboplatin, and paclitaxel are FDA approved for the treatment of NSCLC, but their use in combination with erlotinib is not. Erlotinib is FDA approved for some uses, but it has not been approved by the FDA to treat lung cancer patients like yourself who have not yet undergone chemotherapy; however, the FDA has permitted its use in this research study. Carboplatin and paclitaxel are considered standard of care treatment and you would probably be treated with these drugs or similar drugs even if you decided not to be in the study.
Up to 48 patients will take part in this study. All will be enrolled at M. D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00563784
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ritsuko R. Komaki, MD||M.D. Anderson Cancer Center|