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

Primary Purpose

Breast Cancer, Metastases

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Efaproxiral
Whole Brain Radiation Therapy (WBRT)
Supplemental Oxygen
Sponsored by
Spectrum Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast, Brain, RSR13, efaproxiral, Whole Brain Radiation Therapy, Brain metastases, Metastatic breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia G. Piper Cancer Center, Arizona Oncology Services
  • Arizona Cancer Center, University of Arizona
  • The University of Arkansas for Medical Sciences
  • Alta Bates Comprehensive Cancer Center
  • University of California at Los Angeles
  • Radiological Associates of Sacramento
  • UCSF - Comprehensive Cancer Center
  • Yale University School of Medicine
  • Boca Raton Community Hospital
  • University of Miami Medical
  • University of South Florida - H. Lee Moffitt Cancer Center
  • Emory University Winship Cancer Institute
  • Northwestern University
  • Parkview Research Center
  • Indiana University School of Medicine
  • Siouxland Regional Cancer Center
  • Johns Hopkins Oncology Center
  • Maryland Hematology Oncology
  • Franklin Square Hospital Center
  • Center for Cancer and Blood Disorders
  • Beth Israel Deaconess Medical Center
  • Henry Ford Hospital
  • University of Minnesota Cancer Center
  • Washington University School of Medicine
  • Dent Neurologic Institute
  • Eastchester Center for Cancer Care
  • SUNY Downstate Medical Center
  • University of North Carolina Breast Center
  • Duke University Medical Center
  • University of Cincinnati Division of Hematology-Oncology
  • Cleveland Clinic Hospital
  • Ohio State University
  • Thomas Jefferson University
  • Fox Chase Cancer Center
  • Texas Oncology
  • Texas Oncology
  • Virginia Mason Cancer Center
  • Wenatchee Valley Clinic
  • University of Wisconsin
  • Instituto Medico Especializado Alexander Fleming
  • Instituto de Oncologia A. Roffo
  • Hospital Espanol
  • Instituto Privado de Radioterapia y Oncologia
  • Centro de Terapia Radiante Cumbres (CAICI)
  • LKH-Universitatsklinikum Graz
  • Medical University Innsbruck
  • Hospital Sao Lucas PUC
  • Fundação Pio XII - Hospital do Câncer de Barretos
  • Hospital Erasto Gaertner
  • Velindre Hospital
  • Hospital Santa Rita da Irmandade da Santa Casa
  • Instituto Brasileiro de Controle do Cancer
  • Tom Baker Cancer Centre
  • Cross Cancer Center
  • Juravinski Cancer Centre
  • Ottawa Regional Cancer Centre
  • Princess Margaret Hospital
  • Hopital Maisonneuve-Rosemont
  • CHUM - Campus Notre Dame
  • McGill University
  • Hotel-Dieu de Quebec du CHUQ
  • Centre Hospitalier Universitarie de Service de Radio-Oncologie
  • Cilnica Santa Maria
  • Clinical Hospital Osijek
  • CHU Zagreb University School of Medicine
  • University Hospital for Tumors
  • Centre Georges François Leclerc
  • Centre Oscar Lambret
  • Centre Léon Bérard
  • Hopital de Montbeliard
  • Centre Antioned Lacasagne
  • Centre Hospitalier Lyon Sud
  • CHU Poitiers
  • Centre Rene Huguenin
  • Clinique Armoricaine de
  • Institut Gustave Roussy
  • Hygeia Diagnostic and Therapeutic Center of Athens
  • University of Debrecen
  • University of Szeged
  • Azienda Ospedaliera Maggiore della Carita
  • Ospedale S Chiara, University of Pisa
  • Kaunas Medical University Hospital
  • Institute of Oncology, Vilnius University
  • Hospital Edgardo Rebagliati Martins (ESSALUD)
  • Radiooncologia, Radiation Oncology Center
  • Instituto de Enfermedades Neoplasicas (INEN)
  • Instituto Catalan de Oncologia (ICO)
  • Ciutat Sanitari de Vall d'Hebron
  • Hospital Ramon Y Cajal
  • Clinica Universitaria de Navarra
  • Instituto Valenciano de Oncologia
  • Velindre Hospital
  • Royal Sussex County Hospital
  • Beatson Oncolgy Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Efaproxiral + WBRT + Supplemental Oxygen

WBRT + Supplemental Oxygen

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Response Rate in the Brain at 3 Months
Karnofsky Performance Status & Neurological Signs & Symptoms

Full Information

First Posted
May 18, 2004
Last Updated
May 8, 2013
Sponsor
Spectrum Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00083304
Brief Title
Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer
Acronym
ENRICH
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

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Spectrum Pharmaceuticals, Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Metastases
Keywords
Breast, Brain, RSR13, efaproxiral, Whole Brain Radiation Therapy, Brain metastases, Metastatic breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
368 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Efaproxiral + WBRT + Supplemental Oxygen
Arm Type
Experimental
Arm Title
WBRT + Supplemental Oxygen
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Efaproxiral
Other Intervention Name(s)
RSR13
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Whole Brain Radiation Therapy (WBRT)
Intervention Description
3.0 Gy per day for 10 days (30.0 Gy total) of WBRT.
Intervention Type
Other
Intervention Name(s)
Supplemental Oxygen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
Measured from randomization until death due to any cause.
Secondary Outcome Measure Information:
Title
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.
Title
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.

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

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

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