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Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases
This study has been completed.
First Received: June 2, 2000   Last Updated: August 29, 2009   History of Changes
Sponsor: Allos Therapeutics
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005887
  Purpose

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.


Condition Intervention Phase
Metastatic Cancer
Drug: efaproxiral
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005887

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

Additional Information:
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. 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 ID Numbers: CDR0000067957, ALLOS-RSR13RT-009
Study First Received: June 2, 2000
Last Updated: August 29, 2009
ClinicalTrials.gov Identifier: NCT00005887     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
tumors metastatic to brain

Additional relevant MeSH terms:
Neoplasms
Neoplastic Processes
Antisickling Agents
Pathologic Processes
Radiation-Sensitizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Hematologic Agents
Neoplasm Metastasis
Pharmacologic Actions
Efaproxiral

ClinicalTrials.gov processed this record on November 27, 2009