Radiation Therapy and Stereotactic Radiosurgery With or Without Temozolomide or Erlotinib in Treating Patients With Brain Metastases Secondary to Non-Small Cell Lung Cancer
Metastatic Malignant Neoplasm in the Brain, Recurrent Non-Small Cell Lung Carcinoma, Stage IV Non-Small Cell Lung Cancer AJCC v7
About this trial
This is an interventional treatment trial for Metastatic Malignant Neoplasm in the Brain
Eligibility Criteria
Inclusion Criteria: Histologically confirmed non-small cell lung cancer One to 3 intraparenchymal brain metastases by contrast-enhanced MRI, meeting the following criteria: Well circumscribed tumor(s) Maximum diameter ≤ 4.0 cm If multiple lesions are present and one lesion is at the maximum diameter, the other lesions must not exceed 3.0 cm in maximum diameter No metastases within 10 mm of the optic apparatus such that a portion of the optic nerve or chiasm would be included in the high-dose stereotactic radiosurgery boost field No metastases in the brainstem, midbrain, pons, or medulla No prior complete resection of all known brain metastases Subtotal resection allowed provided residual disease is ≤ 4.0 cm in maximum diameter No clinical or radiographic evidence of progression (other than study lesion[s]) within the past month Patients with brain metastases at initial presentation do not require 1 month of scans documenting stable disease Stable extracranial metastases allowed No known or pre-existing liver metastases No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation Synchronous brain metastases at initial diagnosis allowed Performance status - Zubrod 0-1 Hemoglobin ≥ 8 g/dL Absolute neutrophil count ≥ 1,000/mm^3 Platelet count ≥ 100,000/mm^3 AST < 2 times upper limit of normal (ULN) Alkaline phosphatase < 2 times ULN unless due to elevated bone metastases Total bilirubin normal Lactic dehydrogenase < 2 times ULN Creatinine < 1.5 times ULN No clinically active interstitial lung disease Chronic stable asymptomatic radiographic changes allowed Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative Neurologic function status 0-2 No other major medical illness or psychiatric impairment that would preclude study participation No history of allergic reaction attributed to compounds of similar chemical or biologic composition to erlotinib or temozolomide No concurrent immunotherapy No concurrent biologic therapy, excluding growth factors and epoetin alfa No prior temozolomide or erlotinib No other concurrent chemotherapy during study radiotherapy Other concurrent chemotherapy allowed after study radiotherapy, except for the following: Temozolomide or erlotinib (arm I only) Erlotinib (arm II only) Temozolomide (arm III only) No prior cranial radiotherapy No concurrent intensity-modulated radiotherapy Concurrent radiotherapy to painful bone lesions allowed No concurrent radiotherapy to more than 15% of bone marrow No other concurrent therapy for brain metastases unless a recurrence is detected More than 30 days since prior investigational drugs No concurrent enzyme-inducing antiepileptic drugs including, but not limited to, any of the following (for patients randomized to receive erlotinib): Phenytoin Carbamazepine Rifampin Phenobarbital Primidone Oxcarbazepine No other concurrent investigational drugs No concurrent Hypericum perforatum (St. John's wort) No drugs that alter gastric pH (e.g., proton pump inhibitors or H2 antagonists) within 4 hours after erlotinib administration (arm III patients only)
Sites / Locations
- Arizona Oncology Services Foundation
- Scottsdale Health Care-Osborn
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Kaiser Permanente Los Angeles Medical Center
- Pomona Valley Hospital Medical Center
- Saint Mary's Hospital and Regional Medical Center
- Christiana Care Health System-Christiana Hospital
- Integrated Community Oncology Network-Florida Cancer Center Beaches
- Baptist MD Anderson Cancer Center
- Integrated Community Oncology Network-Southside Cancer Center
- Baptist Medical Center South
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- 21st Century Oncology-Orange Park
- UF Cancer Center at Orlando Health
- 21st Century Oncology-Palatka
- Bay Medical Center
- Integrated Community Oncology Network-Flager Cancer Center
- Tallahassee Memorial HealthCare
- John B Amos Cancer Center
- Saint Alphonsus Cancer Care Center-Boise
- Northwest Community Hospital
- Northwestern University
- Ingalls Memorial Hospital
- Saint John's Hospital
- Parkview Hospital Randallia
- Franciscan Saint Margaret Health-Hammond Campus
- IU Health Methodist Hospital
- Finley Hospital
- Norton Suburban Hospital and Medical Campus
- University of Maryland/Greenebaum Cancer Center
- Saint Agnes Hospital
- Massachusetts General Hospital Cancer Center
- University of Michigan Comprehensive Cancer Center
- Wayne State University/Karmanos Cancer Institute
- West Michigan Cancer Center
- Fairview Ridges Hospital
- Mercy Hospital
- Fairview-Southdale Hospital
- Unity Hospital
- Abbott-Northwestern Hospital
- University of Minnesota/Masonic Cancer Center
- North Memorial Medical Health Center
- Coborn Cancer Center at Saint Cloud Hospital
- Saint Cloud Hospital
- Metro Minnesota Community Oncology Research Consortium
- Park Nicollet Clinic - Saint Louis Park
- United Hospital
- Ridgeview Medical Center
- Saint Louis University Hospital
- Nevada Cancer Research Foundation CCOP
- Renown Regional Medical Center
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
- Riverview Medical Center/Booker Cancer Center
- Sparta Cancer Treatment Center
- University of Rochester
- Mission Hospital-Memorial Campus
- Summa Akron City Hospital/Cooper Cancer Center
- Cleveland Clinic Foundation
- Natalie Warren Bryant Cancer Center at Saint Francis
- Delaware County Memorial Hospital
- Radiation Therapy Oncology Group
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Reading Hospital
- Medical University of South Carolina
- Thompson Cancer Survival Center
- Arlington Cancer Center
- UT Southwestern/Simmons Cancer Center-Dallas
- University of Texas Medical Branch
- M D Anderson Cancer Center
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Huntsman Cancer Institute/University of Utah
- LDS Hospital
- Sentara Norfolk General Hospital
- Virginia Commonwealth University/Massey Cancer Center
- Virginia Mason Medical Center
- University of Wisconsin Hospital and Clinics
- Froedtert and the Medical College of Wisconsin
- Wheaton Franciscan Cancer Care - All Saints
- CancerCare Manitoba
- Ottawa Hospital-Civic Campus
- McGill University Department of Oncology
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Arm I
Arm II
Arm III
Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.