Clinical trial NCT00631371: Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects
Official title: Phase 3b, Randomized, Open-Label Study Of Bevacizumab + Temsirolimus Vs. Bevacizumab + Interferon-Alfa As First-Line Treatment In Subjects With Advanced Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Cell Carcinoma
Keywords: temsirolimus
renal cell carcinoma
kidney cancer
urogenital cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-07
Enrollment: 791
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary objective: Comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response rate (independently assessed), and overall survival.


Eligibility criteria: Inclusion Criteria:

* Histologically and/or cytologically confirmed to have advanced renal cell carcinoma (RCC)
* Majority component of conventional clear-cell type is mandatory
* At least 1 measurable lesion (per RECIST)

Exclusion Criteria:

* Prior systemic treatment for RCC
* Evidence of current or prior central nervous system (CNS) metastases
* Cardiovascular disease
* Pregnant or nursing women
* Additional criteria applies

Primary outcomes:
measure: Progression-Free Survival (PFS): Independent-Assessment
timeFrame: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
Secondary outcomes:
measure: Progression-Free Survival (PFS): Investigator-Assessment
timeFrame: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
measure: Percentage of Participants With Objective Response (Complete Response/Partial Response): Independent-Assessment
timeFrame: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
measure: Overall Survival (OS)
timeFrame: Baseline until death due to any cause, assessed every 8 weeks (up to cut-off date: 19 April 2012)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Hematology Oncology Services of Arkansas
state: Arkansas
city: Chula Vista
country: United States
facility: South County Hematology/Oncology
state: California
city: La Mesa
country: United States
facility: Cancer Center Oncology Medical Group
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Oceanside
country: United States
facility: North County Oncology Medical Clinic
state: California
city: San Diego
country: United States
facility: Medical Oncology Associates - SD
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital Investigational Pharmacy
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: San Francisco
country: United States
facility: Pacific Hematology/Oncology Associates
state: California
city: San francisco
country: United States
facility: San Francisco Oncology Associates
state: California
city: San Francisco
country: United States
facility: Cohen & Hufford MD's INC
state: California
city: New Albany
country: United States
facility: The Jones Clinic, PC
state: Mississippi
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Edmond
country: United States
facility: Edmond Oncology Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: OU Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: OU Physician's Building
state: Oklahoma
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Germantown
country: United States
facility: The Jones Clinic, PC
state: Tennessee
city: Nashville
country: United States
facility: The Vanderbilt Clinic
state: Tennessee
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Rosario
country: Argentina
facility: Centro Oncológico Rosario
state: Santa Fé
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico San Roque
state: Tucuman
city: Santa Fe
country: Argentina
facility: ISIS Clinica Especializado
city: South Brisbane
country: Australia
facility: Mater Adult Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Kurralta Park
country: Australia
facility: Ashford Cancer Center Research
state: South Australia
city: Kurralta Park
country: Australia
facility: Cancer Care SA
city: South Brisbane
country: Australia
facility: Mater Private Hospital
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis - campus Virga Jessa
city: Mont-Godinne
country: Belgium
facility: Cliniques Universitaires de Mont-Godinne UCL
city: Goiania
country: Brazil
facility: Centro Goiano de Oncologia
state: GO
city: Goiania
country: Brazil
facility: Centro Goiano de Oncologia - CGO
state: GO
city: Goiania
country: Brazil
facility: ProCura - Centro Goiano de Pesquisa Clínica Ltda
state: GO
city: Porto Alegre
country: Brazil
facility: Clínica de Oncologia de Porto Alegre Sociedade Simples Ltda
state: Rio Grande do Sul
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer - INCA
state: RJ
city: Ijui
country: Brazil
facility: Associaçao Hospital de Caridade Ijui
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: Clinica de Oncologia de Porto Alegre - Sociedade Simples Ltda.
state: RS
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos
state: Sao Paulo
city: Piracicaba
country: Brazil
facility: Instituto de Oncologia de Piracicaba S/S Ltda
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira - ICESP
state: SP
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional do Cancer - INCA
city: Toronto
country: Canada
facility: Odette Cancer Centre, Sunnybrook Health Sciences Centre
state: Ontario
city: Rimouski
country: Canada
facility: Centre de Sante et de Services Sociaux de Rimouski - Neigette
state: Quebec
city: Santiago
country: Chile
facility: Instituto Nacional del Cancer
state: Region Metropolitana / Chile
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez
city: Santiago
country: Chile
facility: Instituto Clinico Oncologico del Sur
city: Pereira
country: Colombia
facility: Oncologos del Occidente S.A
state: Risaralda
city: Jicin
country: Czech Republic
facility: Oblastni nemocnice Jicin a s
state: Ceska republika
city: Brno
country: Czech Republic
facility: Masarykuv onkologicky ustav
city: Olomouc
country: Czech Republic
facility: Fakultni nemocnice Olomouc
city: Usti nad Labem
country: Czech Republic
facility: Krajska zdravotni, a.s.
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Hyères
country: France
facility: Clinique Sainte Marguerite
city: Le Chesnay
country: France
facility: Hopital Andre Mignot
city: Nimes
country: France
facility: Centre médical Oncogard
city: Poitiers Cedex
country: France
facility: CHU de Poitiers
city: Rouen Cedex
country: France
facility: CHU de Rouen
city: Saint-Herblain-Nantes
country: France
facility: Centre rené Gauducheau
city: Suresnes
country: France
facility: Hopital Foch
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy
city: Berlin
country: Germany
facility: Vivantes Klinikum am Urban, Neztwerk fuer Gesundheit GmbH
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg Eppendorf
city: Hannover
country: Germany
facility: Klinikum Region Hannover, Krankenhaus Siloah
city: Muenchen
country: Germany
facility: TU Muenchen, rechts der Isar
city: Chai Wan
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Nyiregyhaza
country: Hungary
facility: Josa Andras Oktato Korhaz Nonprofit Kft.
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem, Urologiai Klinika
city: Veszprem
country: Hungary
facility: Veszprem Megyei Csolnoky Ferenc
city: Ahmedabad
country: India
facility: Vedanta Institute of Medical Sciences
state: Gujarat
city: Bangalore
country: India
facility: Healthcare Global Enterprises Limited
state: Karnataka
city: Kochi
country: India
facility: Lakeshore Hospital & Research Center Limited
state: Kerala
city: Bhopal
country: India
facility: Jawaharlal Nehru Cancer Hospital, Department of Medical Oncology
state: Madhya Pradesh
city: Mumbai
country: India
facility: Tata Memorial Center
state: Maharashtra
city: Navi Mumbai
country: India
facility: Tata Memorial Centre
state: Maharashtra
city: Pune
country: India
facility: Jehangir Hospital
state: Maharashtra
city: Jaipur
country: India
facility: Searoc Cancer Centre
state: Rajasthan
city: Chennai
country: India
facility: Apollo Hospital
state: Tamil Nadu
city: Kerela
country: India
facility: Regional Cancer Centre
state: Trivandrum
city: Bari
country: Italy
facility: Divisione di Urologia, Azienda Ospedaliera Policlinico Consorziale di Bari
city: Chieti
country: Italy
facility: Sezione di Oncologia Medica Centro di Ricerca Clinica
city: Modena
country: Italy
facility: Unità Operativa di Oncologia, Azienda Ospedaliera Policlinico di Modena
city: Modena
country: Italy
facility: Farmacia del Comitato Etico Provinciale di Modena
city: Perugia
country: Italy
facility: Struttura Complessa di Oncologia Medica Ospedale Santa Maria della Misericordia
city: Roma
country: Italy
facility: IFO- Istituti Fisioterapici Ospitalieri
city: Terni
country: Italy
facility: Azienda Ospedaliera S. Maria
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Korea
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System-Severance Hospital
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Leon
country: Mexico
facility: Hospital Aranda de la Parra
state: Guanajuato
city: Hoofddorp
country: Netherlands
facility: Spaarne Ziekenhuis
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Krakow
country: Poland
facility: Szpital Specjalistyczny im. L. Rydygiera Sp. z o.o.
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej im. sw Jana z Dukli
city: Poznan
country: Poland
facility: Szpital Kliniczny Przemienienia Panskiego UM im. Karola Marcinkowskiego w Poznaniu
city: Warszawa
country: Poland
facility: Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie
city: Warszawa
country: Poland
facility: Centrum Medyczne Ostrobramska NZOZ "Magodent"
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny, Pracownia Badan Cynnosciowych Ukladu Oddechowego, Klinika Chorob Wewnetr
city: Warszawa
country: Poland
facility: Wojskowy Intsytut Medyczny, Zaklad Diagnostyki Laboratoryjnej CSK MON
city: Warszawa
country: Poland
facility: Wojskowy Intsytut Medyczny, Zaklad Medycyny Nuklearnej CSK MON
city: Porto
country: Portugal
facility: Hospital de San Joao
city: Porto
country: Portugal
facility: Hospital de São João
city: Obninsk
country: Russian Federation
facility: Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia
state: Kaluga region
city: Saint-Petersburg
country: Russian Federation
facility: Leningrad Regional Oncology Dispensary
state: Leningradskaya oblast
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Minzdrav of Tatarstan Republic
city: Moscow
country: Russian Federation
facility: Chair of Radiology and Radiotherapy
city: Moscow
country: Russian Federation
facility: N.N. Blokhin Russian Cancer Research Center, Department of Clinical Pharmacology and Chemotherapy
city: Moscow
country: Russian Federation
facility: N.N. Blokhin Russian Cancer Research Center, Department of Urology
city: Moscow
country: Russian Federation
facility: Moscow Scientific Research Oncology Institute P.A. Herzen
city: Nizhni Novgorod
country: Russian Federation
facility: Privolzhskiy District Medical Center of Federal Biomedical Agency
city: Pesochny, Saint-Petersburg
country: Russian Federation
facility: Scientific research Institute of Oncology N.N. Petrov
city: Saint-Petersburg
country: Russian Federation
facility: City Hospital No.26
city: Saint-Petersburg
country: Russian Federation
facility: City Pokrovskaya Hospital
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Institute for Oncology and Radiology of Serbia
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Banska Bystrica
country: Slovakia
facility: Fakultna Nemocnica s poliklinikou F D Roosevelta
city: Banska Bystrica
country: Slovakia
facility: Oddelenie funkcnej diagnostiky
city: Bratislava
country: Slovakia
facility: Klinika pneumologie a ftiziologie FNsP LFUK
city: Bratislava
country: Slovakia
facility: Fakultna Nemocnica s poliklinikou akad L Derera
city: Martin
country: Slovakia
facility: Klinica nuklcarncj mediciny
city: Martin
country: Slovakia
facility: Klinika nuklearnej mediciny JLF UK a Martinskej fakultnej nemocnice
city: Martin
country: Slovakia
facility: Klinika tuberkulozy a plucnych chorob UK JLF a Martinskej fakultnej nemocince
city: Skalica
country: Slovakia
facility: Nemocnica s poliklinikou Skalica
city: Zilina
country: Slovakia
facility: KK MED, s.r.o.
city: Zilina
country: Slovakia
facility: MEDIVASA s.r.o.
city: Zilina
country: Slovakia
facility: Nemocnica s poliklinikou Zilina
city: Kraaifontein
country: South Africa
facility: GVI Oncology Trial Unit
state: Cape Town
city: Mayville
country: South Africa
facility: Westridge Medical Centre
state: Durban
city: Hatfield
country: South Africa
facility: Pretoria Urology Hospital
state: Pretoria
city: Panorama, Cape Town
country: South Africa
facility: Panorama Medical Centre
state: Western Cape
city: Parktown
country: South Africa
facility: University of the Witwatersrand Oncology
city: Port Elizabeth
country: South Africa
facility: Langenhoven Drive Oncology Centre
city: Pretoria
country: South Africa
facility: Dr. Fourie & Voges
city: L'hospitalet de Llobregat
country: Spain
facility: Institut Catala Doncologia
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital Sant Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital del mar de Barcelona
city: Madrid
country: Spain
facility: Hospital de Madrid Norte-Sanchinarro
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
city: Taipei
country: Taiwan
facility: Veterans General Hospital-Taipei
state: ROC
city: Neihu
country: Taiwan
facility: Tri-Service General Hospital
state: Tapei
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei TOC
country: Taiwan
facility: National Taiwan University Hospital
city: Tao Yuan
country: Taiwan
facility: Division of Oncology
city: Chenivtsi
country: Ukraine
facility: Universitet, kafedra onkologyy
city: Chernovtsi
country: Ukraine
facility: A.P Romodanov Itstitut nejrohirurhii
city: Donetsk
country: Ukraine
facility: Uchbobo-naukovyi likuvalnyi kompleks DDMU im. M.Gor'kogo
city: Donetsk
country: Ukraine
facility: Donetskyy Oblasyy protypukhlynnyy Tsenter
city: Donetsk
country: Ukraine
facility: Donetske Obl. clinico-teritorial'ne medichne ob'yednannya
city: Kiev
country: Ukraine
facility: "State Institution ""Institute for Occupational Health of the
city: Kiev
country: Ukraine
facility: R.E.Kavetsky Institute of experimental pathology, oncology and radiobiology NAS of Ukraine,Laborator
city: Kiyv
country: Ukraine
facility: A.P Romodanov Itstitut nejrohirurhii
city: Medychna vul., Ivano-Frankivsk
country: Ukraine
facility: Oblasnyy onkologychnyy dispanser, onkourologichne viddilennya, Ivano-Frankivskiy Derzhavniy Medichni
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: Hampshire
city: Withington
country: United Kingdom
facility: Christie Hospital
state: Manchester
city: Leeds
country: United Kingdom
facility: University of Leeds
state: North Yorkshire
city: London
country: United Kingdom
facility: Guy's Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
citation: Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
citation: Rini BI, Bellmunt J, Clancy J, Wang K, Niethammer AG, Hariharan S, Escudier B. Randomized phase III trial of temsirolimus and bevacizumab versus interferon alfa and bevacizumab in metastatic renal cell carcinoma: INTORACT trial. J Clin Oncol. 2014 Mar 10;32(8):752-9. doi: 10.1200/JCO.2013.50.5305. Epub 2013 Dec 2.