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Metastatic CancerPhase 3NCT00005887

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

A Phase 3 study testing efaproxiral and radiation therapy in people with Metastatic Cancer, run by Spectrum Pharmaceuticals, Inc at 73 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Metastatic Cancer
What is being tested?
efaproxiral and radiation therapy
Type of treatment
Surgery or procedure
How many people
Not given
Where
73 sitesin 9 countries
Study dates
Feb 2000to Jan 2003
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

73 sites in 9 countries.

73 sites in 9 countries

United States35 sites

  • Akron General Medical Center

    Akron, Ohio, 44302

  • Akron City Hospital

    Akron, Ohio, 44309

  • Harbor Hospital Center

    Baltimore, Maryland, 21225

  • St. Agnes Healthcare

    Baltimore, Maryland, 21229

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Alta Bates Comprehensive Cancer Center

    Berkeley, California, 94704

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501-4445

  • Comprehensive Cancer Care Specialists of Boca Raton

    Boca Raton, Florida, 33428

  • Millard Fillmore Hospital

    Buffalo, New York, 14209

  • Lahey Clinic - Burlington

    Burlington, Massachusetts, 01805

  • Cooper Hospital/University Medical Center

    Camden, New Jersey, 08103

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • U.S. Oncology Research Inc.

    Dallas, Texas, 75246

  • Center for Radiation Oncology

    Danville, Virginia, 24541

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • University of Colorado Cancer Center

    Denver, Colorado, 80010

  • California Cancer Care, Inc.

    Greenbrae, California, 94904

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Citrus Memorial Hospital

    Inverness, Florida, 34452

  • Scripps Green Hospital & Scripps Clinic

    La Jolla, California, 92037

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740-6395

  • Tower Hematology Oncology Medical Group

    Los Angeles, California, 90048

  • Memphis Regional Brain Tumor Center

    Memphis, Tennessee, 38104

  • Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group

    Memphis, Tennessee, 38119

  • Veterans Affairs Medical Center - Milwaukee (Zablocki)

    Milwaukee, Wisconsin, 53295

  • Ochsner Clinic

    New Orleans, Louisiana, 70121

  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85001-2071

  • Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284-7811

  • State University of New York - Upstate Medical University

    Syracuse, New York, 13210

  • East Coast Radiation Oncology

    Toms River, New Jersey, 08755

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Canada15 sites

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • CHUS-Hopital Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2L-4M1

  • McGill University

    Montreal, Quebec, H2W 1S6

  • Ottawa Regional Cancer Centre

    Ottawa, Ontario, K1H 1C4

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, G1R 2J6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Newfoundland Cancer Treatment and Research Foundation

    St. John's, Newfoundland and Labrador, A1B 3V6

  • British Columbia Cancer Agency - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

  • St. Boniface General Hospital

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Hungary5 sites

  • Uzsoki Hospital

    Budapest, 1145

  • University of Debrecen

    Debrecen, 1389/990TE-

  • Petz Aladar County Hospital

    Gydr, h-9024

  • Borsod-Abauj-Zemplen County Hospital

    Miskolc, 3501

  • Szeged University

    Szeged, H-6720

Other trials in Hungary

Australia4 sites

  • Peter MacCallum Cancer Institute

    East Melbourne, Victoria, 8006

  • Austin and Repatriation Medical Centre

    Heidelberg West, Victoria, 3081

  • Queensland Radium Institute

    Herston, Queensland, 4029

  • Royal Prince Alfred Hospital Medical Center

    Sydney, New South Wales, 2042

Other trials in Australia

Belgium4 sites

  • Institut Jules Bordet

    Brussels (Bruxelles), 1000

  • Academisch Ziekenhuis der Vrije Universiteit Brussel

    Brussels (Bruxelles), 1090

  • UZ De Pintelaan

    Ghent, B-9000

  • U.Z. Gasthuisberg

    Leuven, B-3000

Other trials in Belgium

France4 sites

  • Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

    Dijon, 21079

  • CHU de la Timone

    Marseille, 13385

  • Hopital de Montbeliard

    Montbéliard, 25200

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310

Other trials in France

Germany2 sites

  • Radiologische Uniklink

    Freiburg im Breisgau, D-79106

  • Universitats-Krankenhaus Eppendorf

    Hamburg, D-20246

Other trials in Germany

Italy2 sites

  • Centro di Riferimento Oncologico - Aviano

    Aviano, 33081

  • Istituto Europeo Di Oncologia

    Milan, 20141

Other trials in Italy

United Kingdom2 sites

  • Western General Hospital

    Edinburgh, Scotland, EH4 2XU

  • Newcastle General Hospital

    Newcastle upon Tyne, England, NE4 6BE

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
efaproxiral, radiation therapy
Keywords
tumors metastatic to brain
Medical subject headings
Neoplasm Metastasis, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • efaproxiralDrug

  • radiation therapyRadiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2003 (estimated)
  2. Study startFeb 2000
  3. Primary completionJan 2003
  4. Study completionJan 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005887
Sponsor's protocol ID
CDR0000067957
Other IDs
ALLOS-RSR13RT-009
Status last verified
Aug 2021
First submitted
2 Jun 2000
Last updated
23 Aug 2021
Results posted
No

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.

    PubMed 16314619

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing efaproxiral and radiation therapy in people with Metastatic Cancer, run by Spectrum Pharmaceuticals, Inc at 73 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, Canada, Hungary, Australia, Belgium and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005887, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.

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