BATTLE Program: Erlotinib in Previously Treated Subjects With Advanced NSCLC
The goal of this clinical research study is to learn if erlotinib hydrochloride (OSI-774, Tarceva®) can help to control NSCLC. The safety of this drug will also be studied, as well as the drug's effect on different cells in the body and the participants' overall response.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II, Open Label Study of Erlotinib (Tarceva) in Previously Treated Subjects With Advanced Non-Small Cell Lung Cancer|
- 8 Week Progression-Free Survival Rate (i.e. disease control rate) [ Time Frame: Radiographic evaluation after cycle 2 (8 weeks of therapy) ] [ Designated as safety issue: Yes ]Primary endpoint, disease control rate at 8 weeks, disease control rate defined as percentage of patients without progression at 8 weeks estimated for each treatment and each treatment-biomarker combination. Under Bayesian framework, inference based on posterior distribution. Both posterior mean and 95% Bayesian credible interval computed. Kaplan-Meier estimates constructed for overall survival and time-to-disease progression. Cox regression applied to assess effect of covariates on time-to-event outcomes.
|Study Start Date:||November 2006|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Erlotinib 150 mg by mouth daily x 28 days.
150 mg by mouth daily x 28 days
Erlotinib hydrochloride is designed to block the activity of an enzyme found on the surface of many tumor cells that may slow tumor growth.
In order to enroll in this study, you must also be enrolled in Protocol 2005-0823: A Biomarker-integrated study in Chemorefractory Patients with Advanced Non-Small Cell Lung Cancer. Protocol 2005-0823 is the screening study in a group of studies called the BATTLE program. Participants in Protocol 2005-0823 are assigned to one of the research studies. The results of your tumor analysis helped the study doctor determine to assign you to this particular research study.
While on study, you will take erlotinib hydrochloride by mouth once a day. Tablets should be taken preferably in the morning 1 hour before or 2 hours after a meal with no more than 7 ounces of water. If you are unable to swallow tablets, you may dissolve the tablets in distilled water. If you forget to take a dose, the last missed dose should be taken as soon as you remember, as long as it is at least 12 hours before the next dose is due to be taken. The next day, you should take the scheduled dose at the usual time. Every attempt should be made to keep from vomiting the medication for at least 30 minutes after taking it. For example, if you feel nauseated before or after taking the erlotinib, anti-nausea medications should be used. The dose of erlotinib hydrochloride may be repeated if vomiting occurs within 30 minutes of taking the tablet. Four (4) weeks is considered 1 treatment cycle.
Every 4 weeks, your complete medical history will be recorded and you will have a physical exam, including measurement of vital signs (blood pressure, pulse, temperature, breathing rate) and weight. You will have blood drawn (about 2 teaspoons) for routine tests. You will have a performance status evaluation (questions about your ability to perform everyday activities). Your study doctor will ask you about any medications you are taking and your smoking history. Every 2 cycles, the tumor will be evaluated by chest x-ray and computed tomography (CT) or magnetic resonance imaging (MRI) scans to evaluate the status of the disease. If you are taking warfarin, you will have blood drawn (about 1-2 teaspoons) to check your blood clotting function weekly for the first 5 weeks of treatment and then every cycle after that.
You may continue receiving erlotinib hydrochloride for as long as the cancer responds to study treatment. Your doctor may decide to take you off this study if you experience intolerable side effects, your medical condition gets worse, or you are unable to comply with study requirements. If you stop study treatment, you may be able to enroll in 1 of the remaining 3 protocols of the BATTLE program. You should discuss this with your doctor.
After you have stopped taking the study treatment, you will have a physical exam, including measurement of vital signs. Blood (about 2 teaspoons) and urine will be collected for routine tests. You will also have blood drawn (about 1-2 teaspoons) to check your blood clotting function. You will have a performance status evaluation, a chest x-ray, and a CT or MRI scan. Following this evaluation, you will be contacted by telephone every 3 months for up to 3 years, to see how you are doing.
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.
This is an investigational study. Erlotinib hydrochloride is approved by the FDA for treatment of NSCLC in patients who have relapsed. Up to 72 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: NCT00410059
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Erminia Massarelli, MD, PHD||M.D. Anderson Cancer Center|