BATTLE Program: Sorafenib in Patients With NSCLC
- To determine the 8 week progression-free survival rate (i.e. disease control rate) in patients with advanced non-small cell lung cancer (NSCLC) who have failed at least one prior chemotherapy regimen.
The secondary objectives of this study will be to:
- Determine the overall response rate
- Determine the overall survival
- Determine the time to disease progression
- Assess the safety/toxicity of the study treatment
- Assess biomarker modulation in the tumor tissue and serum samples from the treatment.
- Assess plasma and intra-tumor concentrations of study treatment
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Sorafenib (BAY 43-9006) in Chemorefractory Patients With Advanced Non-small Cell Lung Cancer (NSCLC)|
- 8-Week Disease Control Rate [ Time Frame: Baseline to 8 weeks ]The disease control rate (DCR) was defined as the proportion of patients who did not meet Response Evaluation Criteria in Solid Tumors (RECIST) criteria for progressive disease (PD) at 8 weeks. Progressive disease was defined as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
- Progression-Free Survival [ Time Frame: From date of randomization until PD or death respectively, up to 3 years ]The Progression-Free Survival (PFS) was measured from date of randomization until progressive disease (PD) or death respectively.
- Tumor Response Measured Every 8-weeks [ Time Frame: At baseline and then every 8 weeks until treatment discontinuation. ]Tumor responses was measured according to RECIST criteria. Tumor responses were defined as: Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Stable Disease (SD): steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive Disease (PD): at least a 20% increase in the sum of LD of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
|Study Start Date:||November 2006|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Sorafenib 400 mg By Mouth Twice Daily for 28 Days.
400 mg By Mouth Twice Daily for 28 Days.
Other Name: BAY 43-9006
BAY 43-9006® (Sorafenib) is an experimental agent designed to stop the growth of cancer cells.
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 treatment studies. The results of your tumor analysis helped the study doctor determine to assign you to this particular treatment study.
While on study, you will take 2 tablets of sorafenib each morning, and again each evening. Sorafenib should be taken with about 1 cup of water on an empty stomach (either 1 hour before a meal or 2 hours after a meal). Sorafenib must be swallowed whole without chewing. If you feel nauseated before or after taking the medication, anti-nausea medications should be used. If you miss a dose, you should skip it and take the next scheduled dose at the right time. Your medication should be stored at room temperature.
Every 4 weeks (1 cycle) your complete medical history will be recorded and you will have a physical exam, including measurement of vital signs (blood pressure, pulse, temperature, and breathing rate) and weight. Blood (about 2 teaspoons) and urine will be drawn for routine tests. You will have a performance status evaluation (questions about your ability to perform everyday activities) and blood drawn (about 1-2 teaspoons) to check your blood clotting function. Your study doctor will also ask you about any medications you are taking and your smoking history. You will be asked to record your weekly blood pressure for the first 6 weeks of study treatment. The study doctor or research nurse will review the log at each clinic visit.
Every 2 cycles, your 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 Coumadin® (warfarin), you will have blood drawn (about 1-2 teaspoons) to check your blood clotting function weekly for the first 6 weeks of treatment and then every cycle after that.
You may continue receiving sorafenib 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 or your medical condition gets worse. If you stop study treatment, you will be allowed to enroll in one of the remaining 3 protocols of the BATTLE program.
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. Sorafenib (BAY 43-9006) has been approved by the FDA for treatment of advanced renal cell cancer; however, it's use in this research study is investigational. Up to 62 patients will take part in this multicenter study. Up to 50 will be enrolled at M. D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411671
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||George Blumenschein, MD||M.D. Anderson Cancer Center|