Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases

August 20, 2021 updated by: Spectrum Pharmaceuticals, Inc

A Phase III, Randomized, Open-Label, Comparative Study of Standard Whole Brain Radiation Therapy With or Without RSR13 in Patients With Brain Metastases

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

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

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2042
        • Royal Prince Alfred Hospital Medical Center
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Queensland Radium Institute
    • Victoria
      • East Melbourne, Victoria, Australia, 8006
        • Peter Maccallum Cancer Institute
      • Heidelberg West, Victoria, Australia, 3081
        • Austin and Repatriation Medical Centre
  • Belgium
      • Brussels (Bruxelles), Belgium, 1000
        • Institut Jules Bordet
      • Brussels (Bruxelles), Belgium, 1090
        • Academisch Ziekenhuis der Vrije Universiteit Brussel
      • Gent, Belgium, B-9000
        • UZ De Pintelaan
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Center - Calgary
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1Z2
        • British Columbia Cancer Agency - Fraser Valley Cancer Centre
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface General Hospital
    • Newfoundland and Labrador
      • St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
        • Newfoundland Cancer Treatment and Research Foundation
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Cancer Centre
    • Ontario
      • Ottawa, Ontario, Canada, K1H 1C4
        • Ottawa Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Fleurimont, Quebec, Canada, J1H 5N4
        • CHUS-Hopital Fleurimont
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill University
      • Montreal, Quebec, Canada, H1T 2M4
        • Maisonneuve-Rosemont Hospital
      • Montreal, Quebec, Canada, H2L-4M1
        • Centre Hospitalier de l'Université de Montréal
      • Quebec City, Quebec, Canada, G1R 2J6
        • Centre Hospitalier Universitaire de Quebec
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
  • France
      • Dijon, France, 21079
        • Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
      • Marseille, France, 13385
        • CHU de la Timone
      • Montbeliard, France, 25200
        • Hopital de Montbeliard
      • Pierre Benite, France, 69310
        • Centre Hospitalier Lyon Sud
  • Germany
      • Freiburg, Germany, D-79106
        • Radiologische Uniklink
      • Hamburg, Germany, D-20246
        • Universitats-Krankenhaus Eppendorf
  • Hungary
      • Budapest, Hungary, 1145
        • Uzsoki Hospital
      • Debrecen, Hungary, 1389/990TE-
        • University of Debrecen
      • Gydr, Hungary, h-9024
        • Petz Aladar County Hospital
      • Miskolc, Hungary, 3501
        • Borsod-Abaúj-Zemplén County Hospital
      • Szeged, Hungary, H-6720
        • Szeged University
  • Italy
      • Aviano, Italy, 33081
        • Centro di Riferimento Oncologico - Aviano
      • Milano, Italy, 20141
        • Istituto Europeo Di Oncologia
  • United Kingdom
    • England
      • Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
        • Newcastle General Hospital
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
        • Western General Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85001-2071
        • St. Joseph's Hospital and Medical Center
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Comprehensive Cancer Center
      • Greenbrae, California, United States, 94904
        • California Cancer Care, Inc.
      • La Jolla, California, United States, 92037
        • Scripps Green Hospital & Scripps Clinic
      • Los Angeles, California, United States, 90048
        • Tower Hematology Oncology Medical Group
    • Colorado
      • Denver, Colorado, United States, 80010
        • University of Colorado Cancer Center
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Comprehensive Cancer Care Specialists of Boca Raton
      • Inverness, Florida, United States, 34452
        • Citrus Memorial Hospital
    • Illinois
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital Cancer Care Institute
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
      • Baltimore, Maryland, United States, 21225
        • Harbor Hospital Center
      • Baltimore, Maryland, United States, 21229
        • St. Agnes Healthcare
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic - Burlington
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Memorial Medical Center
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Hospital/University Medical Center
      • Long Branch, New Jersey, United States, 07740-6395
        • Monmouth Medical Center
      • Toms River, New Jersey, United States, 08755
        • East Coast Radiation Oncology
    • New York
      • Buffalo, New York, United States, 14209
        • Millard Fillmore Hospital
      • Syracuse, New York, United States, 13210
        • State University of New York - Upstate Medical University
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • North Dakota
      • Bismarck, North Dakota, United States, 58501-4445
        • Bismarck Cancer Center
    • Ohio
      • Akron, Ohio, United States, 44302
        • Akron General Medical Center
      • Akron, Ohio, United States, 44309
        • Akron City Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107-5541
        • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group
      • Memphis, Tennessee, United States, 38104
        • Memphis Regional Brain Tumor Center
    • Texas
      • Dallas, Texas, United States, 75246
        • U.S. Oncology Research Inc.
      • Houston, Texas, United States, 77030-4009
        • University of Texas - MD Anderson Cancer Center
      • San Antonio, Texas, United States, 78284-7811
        • University of Texas Health Science Center at San Antonio
    • Virginia
      • Danville, Virginia, United States, 24541
        • Center for Radiation Oncology
      • Richmond, Virginia, United States, 23298-0037
        • Massey Cancer Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53295
        • Veterans Affairs Medical Center - Milwaukee (Zablocki)

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 to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

Spectrum Pharmaceuticals, Inc

Investigators

  • Study Chair: Edward G. Shaw, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

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 (Actual)

February 1, 2000

Primary Completion (Actual)

January 1, 2003

Study Completion (Actual)

January 1, 2003

Study Registration Dates

First Submitted

June 2, 2000

First Submitted That Met QC Criteria

August 28, 2003

First Posted (Estimate)

August 29, 2003

Study Record Updates

Last Update Posted (Actual)

August 23, 2021

Last Update Submitted That Met QC Criteria

August 20, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067957
  • ALLOS-RSR13RT-009

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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