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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00631371
Other study ID # 3066K1-3311
Secondary ID B17710062007-003
Status Completed
Phase Phase 3
First received February 28, 2008
Last updated October 6, 2015
Start date April 2008
Est. completion date April 2015

Study information

Verified date October 2015
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 791
Est. completion date April 2015
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Bevacizumab
Bevacizumab 10 mg/kg intravenous (IV) q8wks
Temsirolimus
Temsirolimus 25 mg IV weekly
Bevacizumab
Bevacizumab 10 mg/kg intravenous (IV) q8wks
Interferon-Alfa 9MU
Interferon-Alfa 9MU SC TIW

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Chile,  Colombia,  Czech Republic,  France,  Germany,  Hong Kong,  Hungary,  India,  Italy,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  Poland,  Portugal,  Russian Federation,  Serbia,  Singapore,  Slovakia,  South Africa,  Spain,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-Free Survival (PFS): Independent-Assessment PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by independent imaging reviewers using Response Evaluation Criteria in Solid Tumors (RECIST) criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions. Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012) No
Secondary Progression-Free Survival (PFS): Investigator-Assessment PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by investigator imaging reviewers using RECIST criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions. Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012) No
Secondary Percentage of Participants With Objective Response (Complete Response/Partial Response): Independent-Assessment Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012) No
Secondary Overall Survival (OS) OS was defined as the time from randomization to death due to any cause, censored at the last date known alive. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). Baseline until death due to any caused, assessed every 8 weeks (up to cut-off date: 19 April 2012) No
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