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

May 8, 2013 updated by: Spectrum Pharmaceuticals, Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

368

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, CP 1417
        • Instituto de Oncologia A. Roffo
      • Buenos Aires, Argentina, CP C1209
        • Hospital Español
      • Cordoba, Argentina, CP 5000
        • Instituto Privado de Radioterapia y Oncologia
      • Rosario, Argentina, 2000
        • Centro de Terapia Radiante Cumbres (CAICI)
    • Cuidad de Buenos Aires
      • Buenos Aires, Cuidad de Buenos Aires, Argentina, C1426ANZ
        • Instituto Médico Especializado Alexander Fleming
  • Austria
      • Graz, Austria, A-8036
        • LKH-Universitätsklinikum Graz
      • Innsbruck, Austria, 6020
        • Medical University Innsbruck
  • Brazil
      • Curitiba, Brazil, 81520-060
        • Hospital Erasto Gaertner
      • Porto Alegre, Brazil, 90610-000
        • Velindre Hospital
      • Porto Alegre, Brazil, CEP 90020-090
        • Hospital Santa Rita da Irmandade da Santa Casa
      • Sao Paulo, Brazil, CEP 03102-002
        • Instituto Brasileiro de Controle do Cancer
    • Fortaleza Ceara
      • Teofilo, Fortaleza Ceara, Brazil, 60430-230
        • Hospital Sao Lucas PUC
    • SP
      • Barretos, SP, Brazil, 14780-400
        • Fundacao Pio XII - Hospital do Cancer de Barretos
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Center
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre
      • Ottawa, Ontario, Canada, K1H 1C4
        • Ottawa Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill University
      • Montreal, Quebec, Canada, H1T 2M4
        • Hôpital Maisonneuve-Rosemont
      • Montreal, Quebec, Canada, H2L 4M1
        • CHUM - Campus Notre Dame
      • Quebec City, Quebec, Canada, G1R 5C3
        • Hotel-Dieu de Quebec du CHUQ
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitarie de Service de Radio-Oncologie
  • Chile
    • Santiago de Chile
      • Providencia, Santiago de Chile, Chile
        • Cilnica Santa Maria
  • Croatia
      • Osijek, Croatia, 4
        • Clinical Hospital Osijek
      • Zagreb, Croatia, 10000
        • CHU Zagreb University School of Medicine
      • Zagreb, Croatia, 197
        • University Hospital For Tumors
  • France
      • Dijon Cedex, France, 21079
        • Centre Georges François Leclerc
      • Lille Cedex, France, 59020
        • Centre Oscar Lambret
      • Lyon Cedex, France, 69373
        • Centre Leon Berard
      • Montbeliard, France, 25209
        • Hopital de Montbeliard
      • Nice, France, 06 189
        • Centre Antioned Lacasagne
      • Pierre-Benite, France, 69310
        • Centre Hospitalier Lyon Sud
      • Poitiers, France, 86021
        • CHU Poitiers
      • Saint-Cloud, France, 92210
        • Centre René Huguenin
      • St. Brieuc, France, 22015
        • Clinique Armoricaine de
      • Villejuif Cedex, France, 94 805
        • Institut Gustave Roussy
  • Greece
      • Athens, Greece, 151 23
        • Hygeia Diagnostic and Therapeutic Center of Athens
  • Hungary
      • Szeged, Hungary, H-6720
        • University of Szeged
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • University of Debrecen
  • Italy
      • Novara, Italy, 28100
        • Azienda Ospedaliera Maggiore Della Carita
      • Pisa, Italy, 56100
        • Ospedale S Chiara, University of Pisa
  • Lithuania
      • Kaunas, Lithuania, 50009
        • Kaunas Medical University Hospital
      • Vilnius, Lithuania, LT-086660
        • Institute of Oncology, Vilnius University
  • Peru
      • Lima, Peru, 11
        • Hospital Edgardo Rebagliati Martins (ESSALUD)
      • Lima, Peru, 27
        • Radiooncologia, Radiation Oncology Center
      • Lima, Peru, 34
        • Instituto de Enfermedades Neoplasicas (INEN)
  • Spain
      • Barcelona, Spain, 08907
        • Instituto Catalán de Oncología (ICO)
      • Barcelona, Spain, 8035
        • Ciutat Sanitari de Vall d'Hebron
      • Madrid, Spain, 28034
        • Hospital Ramón y Cajal
      • Pamplona, Spain, 31008
        • Clinica Universitaria de Navarra
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncologia
  • United Kingdom
      • Brighton, United Kingdom, BN2 5BE
        • Royal Sussex County Hospital
      • Glasgow, United Kingdom, G11 6NT
        • Beatson Oncolgy Center
    • Cardiff
      • Whitchurch, Cardiff, United Kingdom, CF14 2TL
        • Velindre Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Virginia G. Piper Cancer Center, Arizona Oncology Services
      • Tucson, Arizona, United States, 85724-5081
        • Arizona Cancer Center, University of Arizona
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • The University of Arkansas for Medical Sciences
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Comprehensive Cancer Center
      • Los Angeles, California, United States, 90095
        • University of California at Los Angeles
      • Sacramento, California, United States, 95816
        • Radiological Associates of Sacramento
      • San Francisco, California, United States, 94115
        • UCSF - Comprehensive Cancer Center
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Boca Raton Community Hospital
      • Miami, Florida, United States, 33136
        • University of Miami Medical
      • Tampa, Florida, United States, 33612
        • University of South Florida - H. Lee Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University winship Cancer Institute
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Indiana
      • Ft. Wayne, Indiana, United States, 46805
        • Parkview Research Center
      • Indianapolis, Indiana, United States, 46204
        • Indiana University School of Medicine
    • Iowa
      • Sioux City, Iowa, United States, 51101
        • Siouxland Regional Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins Oncology Center
      • Baltimore, Maryland, United States, 21237
        • Franklin Square Hospital Center
      • Baltimore, Maryland, United States, 21236
        • Maryland Hematology Oncology
      • Bethesda, Maryland, United States, 20817
        • Center For Cancer And Blood Disorders
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Cancer Center
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • Amherst, New York, United States, 14226
        • DENT Neurologic Institute
      • Bronx, New York, United States, 10469
        • Eastchester Center for Cancer Care
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Breast Center
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati Division of Hematology-Oncology
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • Texas
      • Dallas, Texas, United States, 75230
        • Texas Oncology
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Cancer Center
      • Wenatchee, Washington, United States, 98801
        • Wenatchee Valley Clinic
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University Of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Efaproxiral + WBRT + Supplemental Oxygen
Drug: Efaproxiral

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.

Other Names:
  • RSR13
Radiation: Whole Brain Radiation Therapy (WBRT)
3.0 Gy per day for 10 days (30.0 Gy total) of WBRT.
Other: Supplemental Oxygen

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.
Active Comparator: WBRT + Supplemental Oxygen
Radiation: Whole Brain Radiation Therapy (WBRT)
3.0 Gy per day for 10 days (30.0 Gy total) of WBRT.
Other: Supplemental Oxygen

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: Measured from randomization until death due to any cause.
Measured from randomization until death due to any cause.

Secondary Outcome Measures

Outcome Measure
Time Frame
Response Rate in the Brain at 3 Months
Time Frame: Assessed at screening, 3 months after end of study treatment and at least 4 weeks after the 3-month scan.
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
Time Frame: Assessed at baseline, 1 month follow-up (FU) visit, 3 month FU visit, and 6 month FU visit.
Assessed at baseline, 1 month follow-up (FU) visit, 3 month FU visit, and 6 month FU visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectrum Pharmaceuticals, Inc

Investigators

  • Study Chair: John Suh, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

May 18, 2004

First Submitted That Met QC Criteria

May 18, 2004

First Posted (Estimate)

May 19, 2004

Study Record Updates

Last Update Posted (Estimate)

May 10, 2013

Last Update Submitted That Met QC Criteria

May 8, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT-016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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