Stage IV Breast Cancer Clinical Trial
Official title:
A Phase 1 Study of AZD2171 and WBRT in Patients With Brain Metastases
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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