Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer

Completed · Phase 3

Conditions studied: Breast Cancer, Metastases

In brief

RSR13 (efaproxiral) is a radiation sensitizer that has shown positive results in a Phase 3, randomized clinical trial of patients with brain metastases. Of 111 eligible breast cancer patients with brain metastases in that trial, 59 patients who received RSR13 prior to radiation therapy had a median survival time that was twice as long as the 52 patients who did not receive RSR13 prior to radiation therapy. RSR13 (efaproxiral) is an experimental drug that increases the amount of oxygen released from blood into the tissues. It is well known that certain types of cancer tumors, including those in brain metastases, lack oxygen. Lack of oxygen in a tumor can reduce the effect of radiation therapy (RT). RSR13 may increase the oxygen level in brain tumors so that radiation therapy works better. This study will enroll up to 360 women with brain metastases from breast cancer, and will evaluate if whole brain radiation therapy given with RSR13 will have a better treatment effect than whole brain radiation therapy alone. RSR13 will be infused intravenously (IV) through a central catheter placed in a central vein. Women randomized (assigned) to receive RSR13, therefore, will need to have a central catheter placed for treatment unless one is already in place.

Key facts

Study ID

NCT00083304

Run by

Spectrum Pharmaceuticals, Inc

People needed

368

Starts

2004-02-01

Expected to finish

2007-06-01

Last updated by the study team

2013-05-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Adult women with brain metastases from breast cancer
• Minimum KPS of 70

You may not qualify if…

• Previous treatment for brain metastases, including brain surgery and any form of radiation to the brain

Where it is running

• Arizona Cancer Center, University of Arizona — Tucson, Arizona, United States
• The University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Alta Bates Comprehensive Cancer Center — Berkeley, California, United States
• University of California at Los Angeles — Los Angeles, California, United States
• Radiological Associates of Sacramento — Sacramento, California, United States
• UCSF - Comprehensive Cancer Center — San Francisco, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Boca Raton Community Hospital — Boca Raton, Florida, United States
• University of Miami Medical — Miami, Florida, United States
• University of South Florida - H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Emory University Winship Cancer Institute — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Parkview Research Center — Fort Wayne, Indiana, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Siouxland Regional Cancer Center — Sioux City, Iowa, United States
• Johns Hopkins Oncology Center — Baltimore, Maryland, United States
• Maryland Hematology Oncology — Baltimore, Maryland, United States
• Franklin Square Hospital Center — Baltimore, Maryland, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• University of Minnesota Cancer Center — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Dent Neurologic Institute — Amherst, New York, United States
• Virginia G. Piper Cancer Center, Arizona Oncology Services — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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