Back to resultsRadiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases
Primary Purpose
Metastatic Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
efaproxiral
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Cancer focused on measuring tumors metastatic to brain
Eligibility Criteria
DISEASE CHARACTERISTICS: Radiographically, histologically, or cytologically confirmed brain metastases with histologically or cytologically confirmed primary malignancy except the following: Small cell lung cancer, germ cell tumors, and lymphomas No leptomeningeal metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Hemoglobin at least 10 g/dL WBC at least 2,000/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL ALT and AST no greater than 3 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Pulmonary: Forced vital capacity and forced expiratory volume at least 50% of normal in patients with significant intrathoracic tumor involvement, chronic obstructive pulmonary disease, interstitial lung disease, or pulmonary embolism Resting and exercise oxygen saturation at least 90% on room air Other: No other concurrent active malignancy from a second histologic site Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy or immunotherapy for brain metastases At least 28 days since prior investigational biologic therapy Chemotherapy: No prior chemotherapy for brain metastases No chemotherapy for brain metastases for at least one month following radiation therapy At least 7 days since prior chemotherapy for primary tumor or extracranial metastases No planned chemotherapy during radiation therapy Endocrine therapy: No prior hormonal therapy for brain metastases Prior or concurrent corticosteroid therapy allowed Radiotherapy: No prior whole brain radiotherapy for brain metastases No prior stereotactic radiosurgery for brain metastases Surgery: Prior surgery allowed for brain metastases if at least one measurable lesion remains Other: At least 28 days since prior investigational drug or device No prior RSR13
Sites / Locations
- St. Joseph's Hospital and Medical Center
- Arizona Cancer Center
- Alta Bates Comprehensive Cancer Center
- California Cancer Care, Inc.
- Scripps Green Hospital & Scripps Clinic
- Tower Hematology Oncology Medical Group
- University of Colorado Cancer Center
- Comprehensive Cancer Care Specialists of Boca Raton
- Citrus Memorial Hospital
- Decatur Memorial Hospital Cancer Care Institute
- Ochsner Clinic
- Harbor Hospital Center
- St. Agnes Healthcare
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Lahey Clinic - Burlington
- University of Massachusetts Memorial Medical Center
- Cooper Hospital/University Medical Center
- Monmouth Medical Center
- East Coast Radiation Oncology
- Millard Fillmore Hospital
- State University of New York - Upstate Medical University
- Comprehensive Cancer Center at Wake Forest University
- Bismarck Cancer Center
- Akron General Medical Center
- Akron City Hospital
- Cleveland Clinic Taussig Cancer Center
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
- Memphis Regional Brain Tumor Center
- Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group
- U.S. Oncology Research Inc.
- University of Texas - MD Anderson Cancer Center
- University of Texas Health Science Center at San Antonio
- Center for Radiation Oncology
- Massey Cancer Center
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
- Royal Prince Alfred Hospital Medical Center
- Queensland Radium Institute
- Peter MacCallum Cancer Institute
- Austin and Repatriation Medical Centre
- Institut Jules Bordet
- Academisch Ziekenhuis der Vrije Universiteit Brussel
- UZ De Pintelaan
- U.Z. Gasthuisberg
- Tom Baker Cancer Center - Calgary
- Cross Cancer Institute
- British Columbia Cancer Agency - Fraser Valley Cancer Centre
- British Columbia Cancer Agency
- St. Boniface General Hospital
- Newfoundland Cancer Treatment and Research Foundation
- Nova Scotia Cancer Centre
- Ottawa Regional Cancer Centre
- Princess Margaret Hospital
- CHUS-Hopital Fleurimont
- Maisonneuve-Rosemont Hospital
- Centre Hospitalier de l'Universite de Montreal
- McGill University
- Centre Hospitalier Universitaire de Quebec
- Allan Blair Cancer Centre
- Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
- CHU de la Timone
- Hopital de Montbeliard
- Centre Hospitalier Lyon Sud
- Radiologische Uniklink
- Universitats-Krankenhaus Eppendorf
- Uzsoki Hospital
- University of Debrecen
- Petz Aladar County Hospital
- Borsod-Abauj-Zemplen County Hospital
- Szeged University
- Centro di Riferimento Oncologico - Aviano
- Istituto Europeo Di Oncologia
- Newcastle General Hospital
- Western General Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005887
First Posted
June 2, 2000
Last Updated
August 20, 2021
Sponsor
Spectrum Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT00005887
Brief Title
Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases
Official Title
A Phase III, Randomized, Open-Label, Comparative Study of Standard Whole Brain Radiation Therapy With or Without RSR13 in Patients With Brain Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 2000 (Actual)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
January 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Pharmaceuticals, Inc
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as RSR13 may make tumor cells more sensitive to radiation therapy.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the brain with or without RSR13 in treating patients who have brain metastases.
Detailed Description
OBJECTIVES:
Compare the median survival time in patients with brain metastases after receiving treatment with whole brain radiotherapy with or without RSR13.
Compare the response rate to these treatment regimens in these patients.
Compare the time to progression after receiving these treatment regimens in these patients.
Compare quality of life in these patients receiving these treatment regimens.
Compare cause of death (neurologic vs nonneurologic death) in these patients after receiving these treatment regimens.
Determine the safety of RSR13 in these patients.
Assess the pharmacokinetics of RSR13 in these patients.
OUTLINE: This is a randomized, open label, comparative, multicenter study. Patients are stratified according to the Radiation Therapy Oncology Group RPA Class (I vs II). Patients are further stratified within the RPA class II stratum according to site of primary cancer (non-small cell lung cancer vs breast vs other). Patients are randomized to one of two treatment arms.
Arm I: Patients receive whole brain radiotherapy 5 days a week for two weeks in conjunction with supplemental oxygen breathing.
Arm II: Patients receive RSR13 IV over 30 minutes followed by whole brain radiotherapy and supplemental oxygen breathing as in arm I.
Quality of life is assessed at the first and last day of radiotherapy, at 1 month, 3 months, and then every 3 months until disease progression.
Patients are followed at 1 month, 3 months, every 3 months until disease progression, and then for survival.
PROJECTED ACCRUAL: A maximum of 408 (204 per treatment arm) patients will be accrued for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
Keywords
tumors metastatic to brain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
efaproxiral
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Radiographically, histologically, or cytologically confirmed brain metastases with histologically or cytologically confirmed primary malignancy except the following:
Small cell lung cancer, germ cell tumors, and lymphomas
No leptomeningeal metastases
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
Karnofsky 70-100%
Life expectancy:
Not specified
Hematopoietic:
Hemoglobin at least 10 g/dL
WBC at least 2,000/mm3
Platelet count at least 75,000/mm3
Hepatic:
Bilirubin no greater than 2.0 mg/dL
ALT and AST no greater than 3 times upper limit of normal
Renal:
Creatinine no greater than 2.0 mg/dL
Pulmonary:
Forced vital capacity and forced expiratory volume at least 50% of normal in patients with significant intrathoracic tumor involvement, chronic obstructive pulmonary disease, interstitial lung disease, or pulmonary embolism
Resting and exercise oxygen saturation at least 90% on room air
Other:
No other concurrent active malignancy from a second histologic site
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
No prior biologic therapy or immunotherapy for brain metastases
At least 28 days since prior investigational biologic therapy
Chemotherapy:
No prior chemotherapy for brain metastases
No chemotherapy for brain metastases for at least one month following radiation therapy
At least 7 days since prior chemotherapy for primary tumor or extracranial metastases
No planned chemotherapy during radiation therapy
Endocrine therapy:
No prior hormonal therapy for brain metastases
Prior or concurrent corticosteroid therapy allowed
Radiotherapy:
No prior whole brain radiotherapy for brain metastases
No prior stereotactic radiosurgery for brain metastases
Surgery:
Prior surgery allowed for brain metastases if at least one measurable lesion remains
Other:
At least 28 days since prior investigational drug or device
No prior RSR13
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward G. Shaw, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85001-2071
Country
United States
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Alta Bates Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
California Cancer Care, Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Scripps Green Hospital & Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Tower Hematology Oncology Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of Colorado Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Comprehensive Cancer Care Specialists of Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Facility Name
Citrus Memorial Hospital
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Decatur Memorial Hospital Cancer Care Institute
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Ochsner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Harbor Hospital Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
Facility Name
St. Agnes Healthcare
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Lahey Clinic - Burlington
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Cooper Hospital/University Medical Center
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Monmouth Medical Center
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740-6395
Country
United States
Facility Name
East Coast Radiation Oncology
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Millard Fillmore Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States
Facility Name
State University of New York - Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Bismarck Cancer Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501-4445
Country
United States
Facility Name
Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44302
Country
United States
Facility Name
Akron City Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44309
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5541
Country
United States
Facility Name
Memphis Regional Brain Tumor Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
U.S. Oncology Research Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284-7811
Country
United States
Facility Name
Center for Radiation Oncology
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States
Facility Name
Veterans Affairs Medical Center - Milwaukee (Zablocki)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States
Facility Name
Royal Prince Alfred Hospital Medical Center
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2042
Country
Australia
Facility Name
Queensland Radium Institute
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Peter MacCallum Cancer Institute
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
8006
Country
Australia
Facility Name
Austin and Repatriation Medical Centre
City
Heidelberg West
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Institut Jules Bordet
City
Brussels (Bruxelles)
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Academisch Ziekenhuis der Vrije Universiteit Brussel
City
Brussels (Bruxelles)
ZIP/Postal Code
1090
Country
Belgium
Facility Name
UZ De Pintelaan
City
Gent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Tom Baker Cancer Center - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
British Columbia Cancer Agency - Fraser Valley Cancer Centre
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
British Columbia Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Newfoundland Cancer Treatment and Research Foundation
City
St. Johns
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Nova Scotia Cancer Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
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
CHUS-Hopital Fleurimont
City
Fleurimont
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal
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
Centre Hospitalier Universitaire de Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hopital de Montbeliard
City
Montbeliard
ZIP/Postal Code
25200
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Facility Name
Radiologische Uniklink
City
Freiburg
ZIP/Postal Code
D-79106
Country
Germany
Facility Name
Universitats-Krankenhaus Eppendorf
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Facility Name
Uzsoki Hospital
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
University of Debrecen
City
Debrecen
ZIP/Postal Code
1389/990TE-
Country
Hungary
Facility Name
Petz Aladar County Hospital
City
Gydr
ZIP/Postal Code
h-9024
Country
Hungary
Facility Name
Borsod-Abauj-Zemplen County Hospital
City
Miskolc
ZIP/Postal Code
3501
Country
Hungary
Facility Name
Szeged University
City
Szeged
ZIP/Postal Code
H-6720
Country
Hungary
Facility Name
Centro di Riferimento Oncologico - Aviano
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Istituto Europeo Di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Newcastle General Hospital
City
Newcastle Upon Tyne
State/Province
England
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
16314619
Citation
Suh JH, Stea B, Nabid A, Kresl JJ, Fortin A, Mercier JP, Senzer N, Chang EL, Boyd AP, Cagnoni PJ, Shaw E. Phase III study of efaproxiral as an adjunct to whole-brain radiation therapy for brain metastases. J Clin Oncol. 2006 Jan 1;24(1):106-14. doi: 10.1200/JCO.2004.00.1768. Epub 2005 Nov 28.
Results Reference
result
Citation
Nabid A, Kresl J, Stea B, et al.: Standard whole brain radiation (WBRT) with supplemental oxygen (O2) with or without RSR13 (efaproxiral) in patients with brain metastases originating from NSCLC: results of a subgroup analysis. [Abstract] J Clin Oncol 22 (Suppl 14): A-7115, 645s, 2004.
Results Reference
result
Citation
Shaw E, Stea B, Pinter T, et al.: Pharmacokinetics (PK) of RSR13 (efaproxiral) predict survival in patients with brain metastases randomized to receive whole brain radiation therapy (WBRT) with or without RSR13 (REACH RT-009). [Abstract] J Clin Oncol 22 (Suppl 14): A-1561, 122s, 2004.
Results Reference
result
Citation
Stea B, Suh J, Shaw E, et al.: Efaproxiral (EFAPROXYN) as an adjunct to whole brain radiation therapy for the treatment of brain metastases originating from breast cancer: updated survival results of the randomized REACH (RT-009) study. [Abstract] Breast Cancer Res Treat 88 (1): A-4064, 2004.
Results Reference
result
Citation
Suh J, Stea BD, Nabid A, et al.: Prognostic factors for survival in patients with brain metastases enrolled on a worldwide phase 3 randomized trial of 538 patients (study RSR13 RT-009). [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-60, S165, 2004.
Results Reference
result
Citation
Suh J, Stea B, Nabid A, et al.: Standard whole brain radiation therapy (WBRT) with supplemental oxygen (O2), with or without RSR13 (efaproxiral) in patients with brain metastases: results of the randomized REACH (RT-009) study. [Abstract] J Clin Oncol 22 (Suppl 14): A-1534, 115s, 2004.
Results Reference
result
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Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases
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