Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer
- Conditions
- Breast CancerMetastases
- Interventions
- Registration Number
- NCT00083304
- Lead Sponsor
- Spectrum Pharmaceuticals, Inc
- Brief Summary
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.
- Detailed Description
The screening process will include documentation of the cancer, which which will require a brain scan and may include a liver scan. Other screening measurements will include a Karnofsky Performance Status (KPS) assessment, measurement of the amount of oxygen in the blood, using a non-invasive device most often placed on the finger, lung function tests that will require blowing into a machine, and an electrocardiogram (ECG). About 2 teaspoons, or 10 mL, of blood will be taken for specific laboratory tests, and a pregnancy test will be done on the blood of women of childbearing potential.
All study patients will receive supplemental oxygen and whole brain radiation therapy (WBRT) (30 Gy, 3 Gy fractions) every weekday for 2 weeks. Half of the patients will be randomized (assigned) to receive RSR13 prior to WBRT, and will need to have a central catheter placed for treatment unless one is already in place. Patients who receive RSR13 will also need to continue to receive oxygen in the clinic until the amount of oxygen in their blood is near normal. This level has returned to near normal in most patients within 1 to 2 hours.
During treatment and follow-up visits, physical and neurological exam, KPS assessment, weight, height, and vital sign measurements, and about 2 teaspoons of blood may be required. Patients will need to return for follow-up visits 1 month after completion of treatment, 2 months later, and every 3 months thereafter until their doctor tells them otherwise.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 368
- Adult women with brain metastases from breast cancer
- Minimum KPS of 70
- Previous treatment for brain metastases, including brain surgery and any form of radiation to the brain
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Efaproxiral + WBRT + Supplemental Oxygen Efaproxiral - Efaproxiral + WBRT + Supplemental Oxygen Whole Brain Radiation Therapy (WBRT) - Efaproxiral + WBRT + Supplemental Oxygen Supplemental Oxygen - WBRT + Supplemental Oxygen Whole Brain Radiation Therapy (WBRT) - WBRT + Supplemental Oxygen Supplemental Oxygen -
- Primary Outcome Measures
Name Time Method Overall Survival Measured from randomization until death due to any cause.
- Secondary Outcome Measures
Name Time Method Response Rate in the Brain at 3 Months Assessed at screening, 3 months after end of study treatment and at least 4 weeks after the 3-month scan. Karnofsky Performance Status & Neurological Signs & Symptoms Assessed at baseline, 1 month follow-up (FU) visit, 3 month FU visit, and 6 month FU visit.
Trial Locations
- Locations (92)
Maryland Hematology Oncology
🇺🇸Baltimore, Maryland, United States
Franklin Square Hospital Center
🇺🇸Baltimore, Maryland, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
University of North Carolina Breast Center
🇺🇸Chapel Hill, North Carolina, United States
Texas Oncology
🇺🇸Fort Worth, Texas, United States
Johns Hopkins Oncology Center
🇺🇸Baltimore, Maryland, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
University of California at Los Angeles
🇺🇸Los Angeles, California, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Siouxland Regional Cancer Center
🇺🇸Sioux City, Iowa, United States
Radiological Associates of Sacramento
🇺🇸Sacramento, California, United States
Dent Neurologic Institute
🇺🇸Amherst, New York, United States
Hospital Sao Lucas PUC
🇧🇷Teofilo, Fortaleza Ceara, Brazil
Hopital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
Eastchester Center for Cancer Care
🇺🇸Bronx, New York, United States
University of Cincinnati Division of Hematology-Oncology
🇺🇸Cincinnati, Ohio, United States
Parkview Research Center
🇺🇸Ft. Wayne, Indiana, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Virginia Mason Cancer Center
🇺🇸Seattle, Washington, United States
Wenatchee Valley Clinic
🇺🇸Wenatchee, Washington, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
University of Miami Medical
🇺🇸Miami, Florida, United States
Alta Bates Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Emory University Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
UCSF - Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Boca Raton Community Hospital
🇺🇸Boca Raton, Florida, United States
University of South Florida - H. Lee Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Hospital Erasto Gaertner
🇧🇷Curitiba, Brazil
Fundação Pio XII - Hospital do Câncer de Barretos
🇧🇷Barretos, SP, Brazil
Velindre Hospital
🇬🇧Whitchurch, Cardiff, United Kingdom
Ottawa Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Hospital Santa Rita da Irmandade da Santa Casa
🇧🇷Porto Alegre, Brazil
Centre Hospitalier Universitarie de Service de Radio-Oncologie
🇨🇦Sherbrooke, Quebec, Canada
Instituto Brasileiro de Controle do Cancer
🇧🇷Sao Paulo, Brazil
CHUM - Campus Notre Dame
🇨🇦Montreal, Quebec, Canada
Cilnica Santa Maria
🇨🇱Providencia, Santiago de Chile, Chile
CHU Zagreb University School of Medicine
🇭🇷Zagreb, Croatia
Clinical Hospital Osijek
🇭🇷Osijek, Croatia
Centre Georges François Leclerc
🇫🇷Dijon Cedex, France
Centre Oscar Lambret
🇫🇷Lille Cedex, France
Centre Léon Bérard
🇫🇷Lyon Cedex, France
Hopital de Montbeliard
🇫🇷Montbeliard, France
Centre Antioned Lacasagne
🇫🇷Nice, France
Centre Rene Huguenin
🇫🇷Saint-Cloud, France
CHU Poitiers
🇫🇷Poitiers, France
Clinique Armoricaine de
🇫🇷St. Brieuc, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre-Benite, France
University of Debrecen
🇭🇺Debrecen, Hajdú-Bihar, Hungary
University of Szeged
🇭🇺Szeged, Hungary
Institut Gustave Roussy
🇫🇷Villejuif Cedex, France
Ospedale S Chiara, University of Pisa
🇮🇹Pisa, Italy
Azienda Ospedaliera Maggiore della Carita
🇮🇹Novara, Italy
Hygeia Diagnostic and Therapeutic Center of Athens
🇬🇷Athens, Greece
Kaunas Medical University Hospital
🇱🇹Kaunas, Lithuania
Institute of Oncology, Vilnius University
🇱🇹Vilnius, Lithuania
Radiooncologia, Radiation Oncology Center
🇵🇪Lima, Peru
Instituto de Enfermedades Neoplasicas (INEN)
🇵🇪Lima, Peru
Instituto Catalan de Oncologia (ICO)
🇪🇸Barcelona, Spain
Ciutat Sanitari de Vall d'Hebron
🇪🇸Barcelona, Spain
Clinica Universitaria de Navarra
🇪🇸Pamplona, Spain
Hospital Ramon Y Cajal
🇪🇸Madrid, Spain
Instituto Valenciano de Oncologia
🇪🇸Valencia, Spain
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
Beatson Oncolgy Center
🇬🇧Glasgow, United Kingdom
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Instituto de Oncologia A. Roffo
🇦🇷Buenos Aires, Argentina
Hospital Espanol
🇦🇷Buenos Aires, Argentina
Virginia G. Piper Cancer Center, Arizona Oncology Services
🇺🇸Phoenix, Arizona, United States
Instituto Privado de Radioterapia y Oncologia
🇦🇷Cordoba, Argentina
Arizona Cancer Center, University of Arizona
🇺🇸Tucson, Arizona, United States
Instituto Medico Especializado Alexander Fleming
🇦🇷Buenos Aires, Cuidad de Buenos Aires, Argentina
McGill University
🇨🇦Montreal, Quebec, Canada
University Hospital for Tumors
🇭🇷Zagreb, Croatia
Centro de Terapia Radiante Cumbres (CAICI)
🇦🇷Rosario, Argentina
LKH-Universitatsklinikum Graz
🇦🇹Graz, Austria
Hospital Edgardo Rebagliati Martins (ESSALUD)
🇵🇪Lima, Peru
The University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Medical University Innsbruck
🇦🇹Innsbruck, Austria
Hotel-Dieu de Quebec du CHUQ
🇨🇦Quebec City, Quebec, Canada
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Cross Cancer Center
🇨🇦Edmonton, Alberta, Canada
Cleveland Clinic Hospital
🇺🇸Cleveland, Ohio, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States