NCT00937482

Cediranib Maleate and Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer

A Phase 1 Study of AZD2171 and WBRT in Patients With Brain Metastases

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Male Breast Cancer
• Stage IV Breast Cancer
• Stage IV Melanoma
• Stage IV Non-small Cell Lung Cancer
• Stage IV Renal Cell Cancer
• Stage IVA Colon Cancer
• Stage IVA Rectal Cancer
• Stage IVB Colon Cancer
• Stage IVB Rectal Cancer
• Tumors Metastatic to Brain

Interventions

Type	Name	Description
DRUG	cediranib maleate	Given orally
RADIATION	whole-brain radiation therapy	Undergo whole-brain radiotherapy

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-03-01
• First posted: 2009-07-13
• Last updated: 2013-03-08

Locations

1 site across 1 country: United States