This phase I trial is studying the side effects and best dose of cediranib maleate when given together with whole brain radiation therapy in treating patients with brain metastases from non-small cell lung cancer. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays and other types of radiation to kill cancer cells and shrink tumors. Giving cediranib maleate together with radiation therapy may kill more tumor cells
PRIMARY OBJECTIVES: I. To determine the safety and tolerability (maximum tolerated dose, or MTD) of AZD2171 when combined with WBRT in patients with brain metastases. SECONDARY OBJECTIVES: I. To describe the objective response rate (ORR) in the central nervous system (CNS), neurologic progression-free survival (N-PFS), overall survival, and cause of death, and to explore the vascular normalization window using serial, noninvasive imaging parameters. OUTLINE: Patients receive oral cediranib maleate on day 1. Patients undergo whole-brain radiotherapy 5 days a week for 3 weeks beginning on day 3. Treatment continues treatment in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Given orally
Undergo whole-brain radiotherapy
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
MTD defined as the dose at which no patients develop treatment-related grade 5 toxicity and less than 30% of patients develop acute dose limiting toxicities (DLT) assessed using NCI CTCAE version 4.0
Time frame: 7 weeks
Objective response in the CNS
Time frame: Up to 1.5 years
Neurologic progression-free survival
N-PFS will be summarized using a Kaplan-Meier survival curve.
Time frame: Time from start of treatment to time of progression in the CNS, assessed up to 1.5 years
Overall survival
Overall survival will be summarized using a Kaplan-Meier survival curve.
Time frame: From study entry until death due to any cause, assessed up to 1.5 years
Cause of death
The proportion of patients who fall into each category will be tabulated.
Time frame: Up to 1.5 years
Vascular MRI studies
Time frame: Up to 1.5 years
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