NCT00871923

Tarceva With Whole Brain Radiation Therapy - Brain Mets From Non-Small Cell Lung Cancer

A Phase II Study to Determine the Efficacy of Tarceva® (Erlotinib Hydrochloride) With Concurrent Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research study is to learn whether Tarceva (erlotinib hydrochloride), when given in addition to whole brain radiation therapy, is better to treat brain metastases in patients with Non-Small Cell Lung Cancer (NSCLC).

Detailed description

The Study Drugs: Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control tumor growth and survival. This may stop tumors from growing. Study Drug Administration: If you are found to be eligible to take part in this study, you will take the study drug on Days 1-6 before receiving radiation therapy. You will take 1 pill each day at least 1 hour before or 2 hours after eating. You will take the study drug while you are receiving radiation therapy. You will continue to take the study drug daily after the radiation therapy is complete for as long as the study doctor thinks it is necessary. You will record at what time each day you take the study drug on a calendar that the will be provided to you. You will bring this calendar with you to each of your study visits. During the time you are taking the study drug, you must tell the research staff if you have any changes in the drugs that you are taking. If you feel you are having any problems from the study drug before starting radiation therapy, you must tell the study doctor right away. Radiation Therapy: After Day 6 of taking the study drug, you will begin radiation therapy. You will receive radiation therapy 1 time each day (Monday through Fridays only) for a total of 14 days. Once a week during radiation therapy: * You will have a physical exam. * You will complete a quality of life questionnaire (at the last week visit) * You will complete a mini-mental status exam (at the last week visit) * You will be asked about any changes in the drugs you may be taking * You will be asked about how you are feeling and any side effects that you may be having * You will have blood drawn (about 1/2 teaspoon) for lab tests if necessary. One month after Radiation therapy follow up: * You will have a follow up visit 1 month after radiation therapy is complete. The study doctor will decide if you will continue to take the study drug at the follow-up visit. The following tests and procedures will be performed: * You will have a physical exam. * You will have an MRI or CT of the brain. * Your vital signs will be recorded. * You will complete a quality of life questionnaire. * You will complete a mini-mental status exam. * You will be asked about any changes in the drugs you may be taking. * You will be asked about how you are feeling and any side effects that you may be having. * You will have blood drawn (about 1/2 teaspoon) for lab tests if necessary. Follow-up Visits (While on Tarceva): If, at the end-of-study visit, the doctor decides that you will continue to take the study drug, you will have a follow-up visit with the research nurse 1 time each month. At these visits, the following tests and procedures will be performed: (If unable to return to MDACC, this visit will be conducted over the telephone and arrangements will be made to mail study Tarceva medication.) * Your medical history will be reviewed. * You will receive a 30-day supply of the study drug. * You will bring in your study drug calendar for the nurse to review. * You will be asked about how you are feeling and any side effects that you may be having. * You will also be asked about any changes in the drugs you may be taking. * Blood (about 1/2 teaspoon) may be drawn for routine tests. The following tests and procedures will be performed every 3 months: * You will have a physical exam. * You will have an MRI or CT of the brain * Your vital signs will be recorded. Follow up visit (Discontinuation of Study Drug): You will have a follow up visit with the research nurse 1 month after your last dose of the study drug, and the following will be performed: (If unable to return to MDACC, this visit will be conducted over the telephone and arrangements will be made to have the study Tarceva medication and medication diary returned by mail.) * Your medical history will be reviewed. * You will be asked about how you are feeling and any side effects that you may be having. * You will return your study drug calendar and any remaining Tarceva tablets to the research nurse. * You will also be asked about any changes in the drug you may be taking * Your vital signs will be recorded. The following tests and procedures will be performed every 3 months (off Tarceva) for the first 2 years then every 6 months thereafter: * You will have a physical exam. * Your medical history will be reviewed. * You will have an MRI or CT of the brain * If you are unable to return for your follow up visits due to physical conditions, you will be contacted by phone. Duration of Study Treatment: You will remain on study for as long as the study doctor thinks you are benefitting from the study drug. You will be taken off study treatment early if the disease gets worse, you experience intolerable side effects, or your doctor thinks that it is no longer in your best interest to continue to receive treatment on this study. This is an investigational study. Erlotinib hydrochloride is FDA approved and commercially available. It has not been FDA approved to treat NSCLC that has spread to the brain. Up to 20 patients will take part in this study. All will be enrolled at MD Anderson.

Conditions

• Non-small Cell Lung Cancer
• Brain Cancer

Interventions

Type	Name	Description
DRUG	Tarceva (Erlotinib hydrochloride)	150 mg by mouth every day beginning Day 1.
RADIATION	Radiation Therapy	Whole Brain Radiation Therapy (WBRT) for total dose of 3500cGy in 14 daily fractions beginning after Day 6.

Timeline

• Start date: 2009-03-26
• Primary completion: 2019-12-04
• Completion: 2019-12-04
• First posted: 2009-03-30
• Last updated: 2021-09-16
• Results posted: 2021-09-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study