Clinical trial NCT00083304: Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer
Official title: A Phase 3 Randomized, Open-label Comparative Study of Standard Whole Brain Radiation Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (Efaproxiral), in Women With Brain Metastases From Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Metastases
Keywords: Breast
Brain
RSR13
efaproxiral
Whole Brain Radiation Therapy
Brain metastases
Metastatic breast cancer
Lead sponsor: Spectrum Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2004-05-19
Enrollment: 368
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Overall Survival
timeFrame: Measured from randomization until death due to any cause.
Secondary outcomes:
measure: Response Rate in the Brain at 3 Months
timeFrame: Assessed at screening, 3 months after end of study treatment and at least 4 weeks after the 3-month scan.
measure: Karnofsky Performance Status & Neurological Signs & Symptoms
timeFrame: Assessed at baseline, 1 month follow-up (FU) visit, 3 month FU visit, and 6 month FU visit.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Virginia G. Piper Cancer Center, Arizona Oncology Services
state: Arizona
city: Tucson
country: United States
facility: Arizona Cancer Center, University of Arizona
state: Arizona
city: Little Rock
country: United States
facility: The University of Arkansas for Medical Sciences
state: Arkansas
city: Berkeley
country: United States
facility: Alta Bates Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: University of California at Los Angeles
state: California
city: Sacramento
country: United States
facility: Radiological Associates of Sacramento
state: California
city: San Francisco
country: United States
facility: UCSF - Comprehensive Cancer Center
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Boca Raton
country: United States
facility: Boca Raton Community Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami Medical
state: Florida
city: Tampa
country: United States
facility: University of South Florida - H. Lee Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Ft. Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Sioux City
country: United States
facility: Siouxland Regional Cancer Center
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins Oncology Center
state: Maryland
city: Baltimore
country: United States
facility: Maryland Hematology Oncology
state: Maryland
city: Baltimore
country: United States
facility: Franklin Square Hospital Center
state: Maryland
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Cancer Center
state: Minnesota
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
city: Bronx
country: United States
facility: Eastchester Center for Cancer Care
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Breast Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Division of Hematology-Oncology
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Dallas
country: United States
facility: Texas Oncology
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Cancer Center
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Clinic
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Instituto Medico Especializado Alexander Fleming
state: Cuidad de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Instituto de Oncologia A. Roffo
city: Buenos Aires
country: Argentina
facility: Hospital Espanol
city: Cordoba
country: Argentina
facility: Instituto Privado de Radioterapia y Oncologia
city: Rosario
country: Argentina
facility: Centro de Terapia Radiante Cumbres (CAICI)
city: Graz
country: Austria
facility: LKH-Universitatsklinikum Graz
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
city: Teofilo
country: Brazil
facility: Hospital Sao Lucas PUC
state: Fortaleza Ceara
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital do Câncer de Barretos
state: SP
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner
city: Porto Alegre
country: Brazil
facility: Velindre Hospital
city: Porto Alegre
country: Brazil
facility: Hospital Santa Rita da Irmandade da Santa Casa
city: Sao Paulo
country: Brazil
facility: Instituto Brasileiro de Controle do Cancer
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Center
state: Alberta
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: CHUM - Campus Notre Dame
state: Quebec
city: Montreal
country: Canada
facility: McGill University
state: Quebec
city: Quebec City
country: Canada
facility: Hotel-Dieu de Quebec du CHUQ
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitarie de Service de Radio-Oncologie
state: Quebec
city: Providencia
country: Chile
facility: Cilnica Santa Maria
state: Santiago de Chile
city: Osijek
country: Croatia
facility: Clinical Hospital Osijek
city: Zagreb
country: Croatia
facility: CHU Zagreb University School of Medicine
city: Zagreb
country: Croatia
facility: University Hospital for Tumors
city: Dijon Cedex
country: France
facility: Centre Georges François Leclerc
city: Lille Cedex
country: France
facility: Centre Oscar Lambret
city: Lyon Cedex
country: France
facility: Centre Léon Bérard
city: Montbeliard
country: France
facility: Hopital de Montbeliard
city: Nice
country: France
facility: Centre Antioned Lacasagne
city: Pierre-Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: CHU Poitiers
city: Saint-Cloud
country: France
facility: Centre Rene Huguenin
city: St. Brieuc
country: France
facility: Clinique Armoricaine de
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy
city: Athens
country: Greece
facility: Hygeia Diagnostic and Therapeutic Center of Athens
city: Debrecen
country: Hungary
facility: University of Debrecen
state: Hajdú-Bihar
city: Szeged
country: Hungary
facility: University of Szeged
city: Novara
country: Italy
facility: Azienda Ospedaliera Maggiore della Carita
city: Pisa
country: Italy
facility: Ospedale S Chiara, University of Pisa
city: Kaunas
country: Lithuania
facility: Kaunas Medical University Hospital
city: Vilnius
country: Lithuania
facility: Institute of Oncology, Vilnius University
city: Lima
country: Peru
facility: Hospital Edgardo Rebagliati Martins (ESSALUD)
city: Lima
country: Peru
facility: Radiooncologia, Radiation Oncology Center
city: Lima
country: Peru
facility: Instituto de Enfermedades Neoplasicas (INEN)
city: Barcelona
country: Spain
facility: Instituto Catalan de Oncologia (ICO)
city: Barcelona
country: Spain
facility: Ciutat Sanitari de Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Ramon Y Cajal
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia
city: Whitchurch
country: United Kingdom
facility: Velindre Hospital
state: Cardiff
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Glasgow
country: United Kingdom
facility: Beatson Oncolgy Center
Study officials:
affiliation: The Cleveland Clinic
name: John Suh, MD
role: STUDY_CHAIR
References: