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

Metastatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005887
• Other study ID #: CDR0000067957
• Secondary ID: ALLOS-RSR13RT-00
• Status: Completed
• Phase: Phase 3
• Start date: February 2000
• Est. completion date: January 2003

Study information

• Verified date: August 2021
• Source: Spectrum Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 metastases.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2003
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Drug:
• efaproxiral

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Institute	East Melbourne	Victoria
Australia	Austin and Repatriation Medical Centre	Heidelberg West	Victoria
Australia	Queensland Radium Institute	Herston	Queensland
Australia	Royal Prince Alfred Hospital Medical Center	Sydney	New South Wales
Belgium	Academisch Ziekenhuis der Vrije Universiteit Brussel	Brussels (Bruxelles)
Belgium	Institut Jules Bordet	Brussels (Bruxelles)
Belgium	UZ De Pintelaan	Gent
Belgium	U.Z. Gasthuisberg	Leuven
Canada	Tom Baker Cancer Center - Calgary	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	CHUS-Hopital Fleurimont	Fleurimont	Quebec
Canada	Nova Scotia Cancer Centre	Halifax	Nova Scotia
Canada	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec
Canada	McGill University	Montreal	Quebec
Canada	Ottawa Regional Cancer Centre	Ottawa	Ontario
Canada	Centre Hospitalier Universitaire de Quebec	Quebec City	Quebec
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Newfoundland Cancer Treatment and Research Foundation	St. Johns	Newfoundland and Labrador
Canada	British Columbia Cancer Agency - Fraser Valley Cancer Centre	Surrey	British Columbia
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	British Columbia Cancer Agency	Vancouver	British Columbia
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
France	Centre de Lutte Contre le Cancer, Georges-Francois Leclerc	Dijon
France	CHU de la Timone	Marseille
France	Hopital de Montbeliard	Montbeliard
France	Centre Hospitalier Lyon Sud	Pierre Benite
Germany	Radiologische Uniklink	Freiburg
Germany	Universitats-Krankenhaus Eppendorf	Hamburg
Hungary	Uzsoki Hospital	Budapest
Hungary	University of Debrecen	Debrecen
Hungary	Petz Aladar County Hospital	Gydr
Hungary	Borsod-Abauj-Zemplen County Hospital	Miskolc
Hungary	Szeged University	Szeged
Italy	Centro di Riferimento Oncologico - Aviano	Aviano
Italy	Istituto Europeo Di Oncologia	Milano
United Kingdom	Western General Hospital	Edinburgh	Scotland
United Kingdom	Newcastle General Hospital	Newcastle Upon Tyne	England
United States	Akron City Hospital	Akron	Ohio
United States	Akron General Medical Center	Akron	Ohio
United States	Harbor Hospital Center	Baltimore	Maryland
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	St. Agnes Healthcare	Baltimore	Maryland
United States	Alta Bates Comprehensive Cancer Center	Berkeley	California
United States	Bismarck Cancer Center	Bismarck	North Dakota
United States	Comprehensive Cancer Care Specialists of Boca Raton	Boca Raton	Florida
United States	Millard Fillmore Hospital	Buffalo	New York
United States	Lahey Clinic - Burlington	Burlington	Massachusetts
United States	Cooper Hospital/University Medical Center	Camden	New Jersey
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	U.S. Oncology Research Inc.	Dallas	Texas
United States	Center for Radiation Oncology	Danville	Virginia
United States	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois
United States	University of Colorado Cancer Center	Denver	Colorado
United States	California Cancer Care, Inc.	Greenbrae	California
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Citrus Memorial Hospital	Inverness	Florida
United States	Scripps Green Hospital & Scripps Clinic	La Jolla	California
United States	Monmouth Medical Center	Long Branch	New Jersey
United States	Tower Hematology Oncology Medical Group	Los Angeles	California
United States	Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group	Memphis	Tennessee
United States	Memphis Regional Brain Tumor Center	Memphis	Tennessee
United States	Veterans Affairs Medical Center - Milwaukee (Zablocki)	Milwaukee	Wisconsin
United States	Ochsner Clinic	New Orleans	Louisiana
United States	Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	Massey Cancer Center	Richmond	Virginia
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	State University of New York - Upstate Medical University	Syracuse	New York
United States	East Coast Radiation Oncology	Toms River	New Jersey
United States	Arizona Cancer Center	Tucson	Arizona
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Hungary,  Italy,  United Kingdom, 

References & Publications (6)

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

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 (

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

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

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, 2

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 — View Citation