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

NCT00083304 | Completed Phase 3 DMC

• 1 other identifier: RT-016
• Study Type: interventional
• Target: 368
• Locations: 15 countries
• Sites: 94

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.

Conditions

Breast Cancer; Metastases

Keywords

Breast; Brain; RSR13; efaproxiral; Whole Brain Radiation Therapy; Brain metastases; Metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Measured from randomization until death due to any cause.

Secondary Outcomes (2)

• 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.

Study Arms (2)

Efaproxiral + WBRT + Supplemental Oxygen

EXPERIMENTAL

Drug: Efaproxiral; Radiation: Whole Brain Radiation Therapy (WBRT); Other: Supplemental Oxygen

WBRT + Supplemental Oxygen

ACTIVE COMPARATOR

Radiation: Whole Brain Radiation Therapy (WBRT); Other: Supplemental Oxygen

Interventions

Efaproxiral DRUG

75 mg/kg, administered over 30 minutes via a central venous access device (CVAD). Administered 30 minutes prior to the start of whole brain radiation therapy (WBRT) on each WBRT treatment day for 10 days.

Also known as: RSR13

Efaproxiral + WBRT + Supplemental Oxygen

Whole Brain Radiation Therapy (WBRT) RADIATION

3.0 Gy per day for 10 days (30.0 Gy total) of WBRT.

Efaproxiral + WBRT + Supplemental Oxygen; WBRT + Supplemental Oxygen

Supplemental Oxygen OTHER

4 L/minute by nasal cannula. Administered at least 35 minutes prior to WBRT, during WBRT and until 15 minutes after completion of WBRT on all WBRT treatment days.

Efaproxiral + WBRT + Supplemental Oxygen; WBRT + Supplemental Oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead

Study Sites (94)

Virginia G. Piper Cancer Center, Arizona Oncology Services

Phoenix, Arizona, 85013, United States

Location

Arizona Cancer Center, University of Arizona

Tucson, Arizona, 85724-5081, United States

Location

The University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Alta Bates Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

University of California at Los Angeles

Los Angeles, California, 90095, United States

Location

Radiological Associates of Sacramento

Sacramento, California, 95816, United States

Location

UCSF - Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Boca Raton Community Hospital

Boca Raton, Florida, 33486, United States

Location

University of Miami Medical

Miami, Florida, 33136, United States

Location

University of South Florida - H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Parkview Research Center

Fort Wayne, Indiana, 46805, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46204, United States

Location

Siouxland Regional Cancer Center

Sioux City, Iowa, 51101, United States

Location

Johns Hopkins Oncology Center

Baltimore, Maryland, 21231, United States

Location

Maryland Hematology Oncology

Baltimore, Maryland, 21236, United States

Location

Franklin Square Hospital Center

Baltimore, Maryland, 21237, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Dent Neurologic Institute

Amherst, New York, 14226, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Eastchester Center for Cancer Care

The Bronx, New York, 10469, United States

Location

University of North Carolina Breast Center

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Cincinnati Division of Hematology-Oncology

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic Hospital

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Texas Oncology

Dallas, Texas, 75230, United States

Location

Texas Oncology

Fort Worth, Texas, 76104, United States

Location

Virginia Mason Cancer Center

Seattle, Washington, 98101, United States

Location

Wenatchee Valley Clinic

Wenatchee, Washington, 98801, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Instituto Medico Especializado Alexander Fleming

Buenos Aires, Cuidad de Buenos Aires, C1426ANZ, Argentina

Location

Instituto de Oncologia A. Roffo

Buenos Aires, CP 1417, Argentina

Location

Hospital Espanol

Buenos Aires, CP C1209, Argentina

Location

Instituto Privado de Radioterapia y Oncologia

Córdoba, CP 5000, Argentina

Location

Centro de Terapia Radiante Cumbres (CAICI)

Rosario, 2000, Argentina

Location

LKH-Universitatsklinikum Graz

Graz, A-8036, Austria

Location

Medical University Innsbruck

Innsbruck, 6020, Austria

Location

Hospital Sao Lucas PUC

Teófilo, Fortaleza Ceara, 60430-230, Brazil

Location

Fundação Pio XII - Hospital do Câncer de Barretos

Barretos, São Paulo, 14780-400, Brazil

Location

Hospital Erasto Gaertner

Curitiba, 81520-060, Brazil

Location

Velindre Hospital

Porto Alegre, 90610-000, Brazil

Location

Hospital Santa Rita da Irmandade da Santa Casa

Porto Alegre, CEP 90020-090, Brazil

Location

Instituto Brasileiro de Controle do Cancer

São Paulo, CEP 03102-002, Brazil

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Center

Edmonton, Alberta, T6G 1Z2, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

CHUM - Campus Notre Dame

Montreal, Quebec, H2L 4M1, Canada

Location

McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Hotel-Dieu de Quebec du CHUQ

Québec, Quebec, G1R 5C3, Canada

Location

Centre Hospitalier Universitarie de Service de Radio-Oncologie

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Cilnica Santa Maria

Providencia, Santiago de Chile, Chile

Location

Clinical Hospital Osijek

Osijek, 4, Croatia

Location

CHU Zagreb University School of Medicine

Zagreb, 10000, Croatia

Location

University Hospital for Tumors

Zagreb, 197, Croatia

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Hopital de Montbeliard

Montbéliard, 25209, France

Location

Centre Antioned Lacasagne

Nice, 06 189, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

Clinique Armoricaine de

Saint-Brieuc, 22015, France

Location

Centre Rene Huguenin

Saint-Cloud, 92210, France

Location

Institut Gustave Roussy

Villejuif, 94 805, France

Location

Hygeia Diagnostic and Therapeutic Center of Athens

Athens, 151 23, Greece

Location

University of Debrecen

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

University of Szeged

Szeged, H-6720, Hungary

Location

Azienda Ospedaliera Maggiore della Carita

Novara, 28100, Italy

Location

Ospedale S Chiara, University of Pisa

Pisa, 56100, Italy

Location

Kaunas Medical University Hospital

Kaunas, 50009, Lithuania

Location

Institute of Oncology, Vilnius University

Vilnius, LT-086660, Lithuania

Location

Hospital Edgardo Rebagliati Martins (ESSALUD)

Lima, 11, Peru

Location

Radiooncologia, Radiation Oncology Center

Lima, 27, Peru

Location

Instituto de Enfermedades Neoplasicas (INEN)

Lima, 34, Peru

Location

Instituto Catalan de Oncologia (ICO)

Barcelona, 08907, Spain

Location

Ciutat Sanitari de Vall d'Hebron

Barcelona, 8035, Spain

Location

Hospital Ramon Y Cajal

Madrid, 28034, Spain

Location

Clinica Universitaria de Navarra

Pamplona, 31008, Spain

Location

Instituto Valenciano de Oncologia

Valencia, 46009, Spain

Location

Velindre Hospital

Whitchurch, Cardiff, CF14 2TL, United Kingdom

Location

Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

Location

Beatson Oncolgy Center

Glasgow, G11 6NT, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis; Brain Neoplasms

Interventions

efaproxiral

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• John Suh, MD

  The Cleveland Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 18, 2004
• First Posted: May 19, 2004
• Study Start: February 1, 2004
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: May 10, 2013

Record last verified: 2013-05

Locations

CL (1); AU (2); IT (2); HU (2); LI (2); AR (5); CA (10); PE (3); FR (10); CR (3); GB (3); ES (5); US (39); BR (6); GR (1)