Tarceva With Whole Brain Radiation Therapy - Brain Mets From Non-Small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00871923|
Recruitment Status : Active, not recruiting
First Posted : March 30, 2009
Last Update Posted : September 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer Brain Cancer||Drug: Tarceva (Erlotinib hydrochloride) Radiation: Radiation Therapy||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||March 2009|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
Experimental: Tarceva + RT
Tarceva (Erlotinib hydrochloride) + Radiation Therapy. Tarceva 150 mg by mouth every day beginning Day 1. Whole Brain Radiation Therapy (WBRT) for total dose of 3500cGy in 14 daily fractions beginning after Day 6.
Drug: Tarceva (Erlotinib hydrochloride)
150 mg by mouth every day beginning Day 1.
Other Name: OSI-774Radiation: Radiation Therapy
Whole Brain Radiation Therapy (WBRT) for total dose of 3500cGy in 14 daily fractions beginning after Day 6.
- Median Survival [ Time Frame: End-of-study visit 1 month after radiation therapy completed, and follow-up visits every 3 months. ]
- Quality of Life Improvement [ Time Frame: Baseline, last radiation therapy visit, and one month after radiation therapy ]Quality of life as assessed with the Spitzer Quality of Life Index and the Folstein Mini-Mental Status Exam.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00871923
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||James Welsh, MD||M.D. Anderson Cancer Center|