BATTLE Program: Tarceva and Targretin in Patients With NSCLC
The goal of this clinical research study is to evaluate the effectiveness of Tarceva® (OSI-774, erlotinib hydrochloride) in combination with Targretin® (bexarotene) in treating NSCLC. The safety of this treatment will also be studied, as well as the treatment's effect on different cells in the body and the participants' overall response.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Erlotinib (Tarceva) in Combination With Bexarotene (Targretin) in Chemorefractory Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)|
- 8 week Progression-Free Survival Rate (i.e. disease control rate) [ Time Frame: Reimaging and re-biopsy (optional) of the tumor performed to assess the effects of the drugs on tumor markers after completing 2 cycles of therapy. ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2006|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: Bexarotene + Erlotinib
Bexarotene 400 mg/m^2 by mouth daily x 28 Days. Erlotinib 150 mg by mouth daily x 28 Days.
400 mg/m^2 by mouth daily x 28 Days
Other Name: TargretinDrug: Erlotinib
150 mg by mouth daily x 28 Days
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Erlotinib hydrochloride is designed to help block the activity of an enzyme that is believed to play an important role in cell growth. Researchers want to find out if blocking these enzymes will slow tumor growth. Bexarotene is designed to control cancer cell growth and division.
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 and bexarotene by mouth once a day. Erlotinib hydrochloride 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 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.
Bexarotene capsules should be taken with or immediately after a meal. If you miss a dose, take it as soon as possible, with food. However, if it is nearly time for your next dose, skip the missed dose and continue your dose schedule as before.
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 medication, anti-nausea medications should be used.
The erlotinib hydrochloride tablets and bexarotene capsules should be stored at room temperature. Bexarotene capsules should not be stored near heating devices, high temperatures or humidity, or where children or pets have access to them. Bexarotene capsules should be protected from sunlight.
Every 4 weeks (1 cycle) your 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. You will have routine blood tests (about 2 teaspoons) and a performance status evaluation (questions about your ability to perform everyday activities). You will have blood drawn (about 1-2 teaspoons) to check you thyroid function. You will also have blood drawn (about 1-2 teaspoons) to check your lipid profile weekly for the first 4 weeks and then every cycle after that. Your study doctor will also ask you about any medications you are taking and your smoking history.
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 5 weeks of treatment and then every cycle after that.
You may continue receiving erlotinib hydrochloride and bexarotene 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.
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.
This is an investigational study. Erlotinib hydrochloride is approved by the FDA for treatment of NSCLC in patients who have relapsed. Bexarotene is approved by the FDA for the treatment of cutaneous T-cell lymphoma (CTCL). Their use together in this study is investigational. Up to 72 patients will take part in this multicenter study. All will be enrolled at M. D. Anderson.
|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|