Status:
TERMINATED
Radiation Therapy and Stereotactic Radiosurgery With or Without Temozolomide or Erlotinib in Treating Patients With Brain Metastases Secondary to Non-Small Cell Lung Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Collaborating Sponsors:
Radiation Therapy Oncology Group
Conditions:
Metastatic Malignant Neoplasm in the Brain
Recurrent Non-Small Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This randomized phase III trial is studying whole-brain radiation therapy and stereotactic radiosurgery with or without temozolomide or erlotinib to see how well they work compared to whole-brain radi...
Detailed Description
PRIMARY OBJECTIVES: I. Compare survival in patients with non-small cell lung cancer and brain metastases treated with whole brain radiotherapy and stereotactic radiosurgery with vs without temozolomi...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
October 6 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00096265
Start Date
October 6 2004
End Date
April 1 2012
Last Update
March 9 2018
Active Locations (83)
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1
Arizona Oncology Services Foundation
Scottsdale, Arizona, United States, 85260
2
Scottsdale Health Care-Osborn
Scottsdale, Arizona, United States, 85260
3
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505
4
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027