This phase II open-label study will be performed to evaluate the response rate of brain metastases from lung and breast tumors under treatment with WBRT and lapatinib.
Patients with breast or lung cancer who have developed brain metastases will be treated with WBRT (30Gy in 10 fractions) and lapatinib 1250mg once daily, followed by lapatinib treatment 1500mg once daily for a total duration of 6 weeks. At the 6 weeks timepoint, radiological assessment with brain MRI will take place to evaluate the response of the patients. Subsequent to the 6 weeks treatment period with lapatinib, the patients may discontinue lapatinib as monotherapy and the physicians can proceed with any therapy, according to their discretion. The patients will be followed-up every 12 weeks for disease progression and survival.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Co-administration of lapatinib 1250mg once daily during the WBRT period (2 weeks)and then monotherapy with lapatinib 1500mg once daily for 4 weeks.
General Hospital of Athens 'Hippokratio', 2nd Dept of Internal Medicine
Athens, Greece
Sotiria General Hospital, 3rd Dept of Medicine, Oncology Unit
Athens, Greece
General Peripheral Hospital of Athens "Alexandra"
Response rate in brain as assessed by volumetric analysis of brain Mangnetic Resonance Imaging (MRI).
Time frame: At the 6 weeks timepoint, radiological assessment with brain MRI will take place to evaluate the response of the patients
Response rate for systemic disease
Chest, abdomen, and pelvic Computerized Tomography (CT) scans will be performed at the 6 weeks timepoint to evaluate the response for systemic disease
Time frame: At 6 weeks
Time To Progression in brain and/or non-Central Nervous System (CNS)
Time frame: At the 6 weeks timepoint, radiological assessment with brain MRI will take place to evaluate the response of the patients.The patients will be followed-up every 12 weeks for disease progression and survival.
Safety and tolerability of proposed schema. Adverse Events (AEs) of all participants will be recorded and assessed upon signature of the informed consent form, until 30 days after the last administration of study treatment.
Adverse Events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 criteria and will be reported in a frequency table according to the highest severity grade observed per patient.
Time frame: 10 weeks (6 weeks therapy + 4 weeks follow-up period for AEs)
To explore the 20% volumetric reduction of brain metastatic lesions as a meaningful threshold of CNS response.
Time frame: At the 6 weeks timepoint, radiological assessment with brain MRI will take place to evaluate the response of the patients.
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Athens, Greece
Agii Anargiri Cancer Hospital, 3rd Dept of Medical Oncology
Athens, Greece
Hygeia Hospital, 1st Dept of Medical Oncology
Athens, Greece
Hygeia Hospital, 2nd Dept of Medical Oncology
Athens, Greece
Metropolitan Hospital, 1st Dept of Medical Oncology
Athens, Greece
Metropolitan Hospital, 2nd Dept of Medical Oncology
Athens, Greece
Chania General Hospital, Oncology Section
Chania, Greece
Ioannina University Hospital, Dept of Medical Oncology
Ioannina, Greece
...and 3 more locations