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 2016 (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)
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00563784
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ritsuko R. Komaki, MD||M.D. Anderson Cancer Center|