Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects
- Conditions
- Renal Cell Carcinoma
- Interventions
- Registration Number
- NCT00631371
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 791
- 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)
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Interferon-Alfa 9MU Bevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW 1 Temsirolimus Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly 1 Bevacizumab Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly 2 Bevacizumab Bevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS): Independent-Assessment Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012) 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.
- Secondary Outcome Measures
Name Time Method Progression-Free Survival (PFS): Investigator-Assessment Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012) 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.
Percentage of Participants With Objective Response (Complete Response/Partial Response): Independent-Assessment Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012) 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.
Overall Survival (OS) Baseline until death due to any cause, assessed every 8 weeks (up to cut-off date: 19 April 2012) 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).
Trial Locations
- Locations (169)
Uzsoki Utcai Korhaz
ðŸ‡ðŸ‡ºBudapest, Hungary
Fundacion Arturo Lopez Perez
🇨🇱Santiago, Chile
Pamela Youde Nethersole Eastern Hospital
ðŸ‡ðŸ‡°Chai Wan, Hong Kong
Klinika pneumologie a ftiziologie FNsP LFUK
🇸🇰Bratislava, Slovakia
Nemocnica s poliklinikou Skalica
🇸🇰Skalica, Slovakia
A.P Romodanov Itstitut nejrohirurhii
🇺🇦Kiyv, Ukraine
Josa Andras Oktato Korhaz Nonprofit Kft.
ðŸ‡ðŸ‡ºNyiregyhaza, Hungary
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Veszprem Megyei Csolnoky Ferenc
ðŸ‡ðŸ‡ºVeszprem, Hungary
Vedanta Institute of Medical Sciences
🇮🇳Ahmedabad, Gujarat, India
The Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Jehangir Hospital
🇮🇳Pune, Maharashtra, India
UCLA Medical Center
🇺🇸Los Angeles, California, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Mater Adult Hospital
🇦🇺South Brisbane, Queensland, Australia
Centro Goiano de Oncologia
🇧🇷Goiania, GO, Brazil
ZNA Middelheim
🇧🇪Antwerpen, Belgium
ISIS Clinica Especializado
🇦🇷Santa Fe, Argentina
Cliniques Universitaires de Mont-Godinne UCL
🇧🇪Mont-Godinne, Belgium
Instituto Nacional del Cancer
🇨🇱Santiago, Region Metropolitana / Chile, Chile
Centro Medico San Roque
🇦🇷San Miguel de Tucuman, Tucuman, Argentina
Centre médical Oncogard
🇫🇷Nimes, France
Centre rené Gauducheau
🇫🇷Saint-Herblain-Nantes, France
Ashford Cancer Center Research
🇦🇺Kurralta Park, South Australia, Australia
Odette Cancer Centre, Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Fundação Pio XII - Hospital de Câncer de Barretos
🇧🇷Barretos, Sao Paulo, Brazil
Instituto Clinico Oncologico del Sur
🇨🇱Santiago, Chile
Fakultni nemocnice Olomouc
🇨🇿Olomouc, Czech Republic
Krajska zdravotni, a.s.
🇨🇿Usti nad Labem, Czech Republic
Centro Goiano de Oncologia - CGO
🇧🇷Goiania, GO, Brazil
Oncologos del Occidente S.A
🇨🇴Pereira, Risaralda, Colombia
CHU de Rouen
🇫🇷Rouen Cedex, France
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Jessa Ziekenhuis - campus Virga Jessa
🇧🇪Hasselt, Belgium
Oblastni nemocnice Jicin a s
🇨🇿Jicin, Ceska republika, Czech Republic
Hopital Foch
🇫🇷Suresnes, France
Instituto Nacional do Cancer - INCA
🇧🇷Rio de Janeiro, Brazil
Clinica de Oncologia de Porto Alegre - Sociedade Simples Ltda.
🇧🇷Porto Alegre, RS, Brazil
Cancer Care SA
🇦🇺Kurralta Park, Australia
Mater Private Hospital
🇦🇺South Brisbane, Australia
Clinique Sainte Marguerite
🇫🇷Hyères, France
Hospital Aranda de la Parra
🇲🇽Leon, Guanajuato, Mexico
Universitaetsklinikum Hamburg Eppendorf
🇩🇪Hamburg, Germany
Petz Aladar Megyei Oktato Korhaz
ðŸ‡ðŸ‡ºGyor, Hungary
Centrum Onkologii Ziemi Lubelskiej im. sw Jana z Dukli
🇵🇱Lublin, Poland
Wojskowy Intsytut Medyczny, Zaklad Medycyny Nuklearnej CSK MON
🇵🇱Warszawa, Poland
Tata Memorial Center
🇮🇳Mumbai, Maharashtra, India
Yonsei University Health System-Severance Hospital
🇰🇷Seoul, Korea, Republic of
Sezione di Oncologia Medica Centro di Ricerca Clinica
🇮🇹Chieti, Italy
Masarykuv onkologicky ustav
🇨🇿Brno, Czech Republic
Searoc Cancer Centre
🇮🇳Jaipur, Rajasthan, India
Regional Cancer Centre
🇮🇳Kerela, Trivandrum, India
Hopital Andre Mignot
🇫🇷Le Chesnay, France
CHU de Poitiers
🇫🇷Poitiers Cedex, France
Samsung Medical Center
🇰🇷Seoul, Korea, Korea, Republic of
TU Muenchen, rechts der Isar
🇩🇪Muenchen, Germany
Apollo Hospital
🇮🇳Chennai, Tamil Nadu, India
Divisione di Urologia, Azienda Ospedaliera Policlinico Consorziale di Bari
🇮🇹Bari, Italy
Farmacia del Comitato Etico Provinciale di Modena
🇮🇹Modena, Italy
Klinikum Region Hannover, Krankenhaus Siloah
🇩🇪Hannover, Germany
Queen Mary Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Unità Operativa di Oncologia, Azienda Ospedaliera Policlinico di Modena
🇮🇹Modena, Italy
Spaarne Ziekenhuis
🇳🇱Hoofddorp, Netherlands
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Wojskowy Intsytut Medyczny, Zaklad Diagnostyki Laboratoryjnej CSK MON
🇵🇱Warszawa, Poland
GVI Oncology Trial Unit
🇿🇦Kraaifontein, Cape Town, South Africa
Westridge Medical Centre
🇿🇦Mayville, Durban, South Africa
Christie Hospital
🇬🇧Withington, Manchester, United Kingdom
National Cancer Centre Singapore
🇸🇬Singapore, Singapore
Fakultna Nemocnica s poliklinikou akad L Derera
🇸🇰Bratislava, Slovakia
Hospital del mar de Barcelona
🇪🇸Barcelona, Spain
City Pokrovskaya Hospital
🇷🇺Saint-Petersburg, Russian Federation
China Medical University Hospital
🇨🇳Taichung, Taiwan
Uchbobo-naukovyi likuvalnyi kompleks DDMU im. M.Gor'kogo
🇺🇦Donetsk, Ukraine
"State Institution ""Institute for Occupational Health of the
🇺🇦Kiev, Ukraine
University of the Witwatersrand Oncology
🇿🇦Parktown, South Africa
Dr. Fourie & Voges
🇿🇦Pretoria, South Africa
Nemocnica s poliklinikou Zilina
🇸🇰Zilina, Slovakia
Tri-Service General Hospital
🇨🇳Neihu, Tapei, Taiwan
Donetskyy Oblasyy protypukhlynnyy Tsenter
🇺🇦Donetsk, Ukraine
Instituto Valenciano de OncologÃa
🇪🇸Valencia, Spain
Veterans General Hospital-Taipei
🇨🇳Taipei, ROC, Taiwan
Division of Oncology
🇨🇳Tao Yuan, Taiwan
Langenhoven Drive Oncology Centre
🇿🇦Port Elizabeth, South Africa
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Sant Creu I Sant Pau
🇪🇸Barcelona, Spain
Pretoria Urology Hospital
🇿🇦Hatfield, Pretoria, South Africa
National Taiwan University Hospital
🇨🇳Taipei TOC, Taiwan
Hospital de Madrid Norte-Sanchinarro
🇪🇸Madrid, Spain
ClÃnica de Oncologia de Porto Alegre Sociedade Simples Ltda
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil
University of Leeds
🇬🇧Leeds, North Yorkshire, United Kingdom
Medical Oncology Associates - SD
🇺🇸San Diego, California, United States
Sharp Memorial Hospital Investigational Pharmacy
🇺🇸San Diego, California, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Pacific Hematology/Oncology Associates
🇺🇸San Francisco, California, United States
San Francisco Oncology Associates
🇺🇸San francisco, California, United States
Cohen & Hufford MD's INC
🇺🇸San Francisco, California, United States
The Vanderbilt Clinic
🇺🇸Nashville, Tennessee, 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
IFO- Istituti Fisioterapici Ospitalieri
🇮🇹Roma, Italy
Azienda Ospedaliera S. Maria
🇮🇹Terni, Italy
Institut Gustave Roussy
🇫🇷Villejuif Cedex, France
Instituto Nacional de Cancer - INCA
🇧🇷Rio de Janeiro, RJ, Brazil
Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira - ICESP
🇧🇷Sao Paulo, SP, Brazil
City Hospital No.26
🇷🇺Saint-Petersburg, Russian Federation
Sharp Rees-Stealy
🇺🇸San Diego, California, United States
South County Hematology/Oncology
🇺🇸Chula Vista, California, United States
Hematology Oncology Services of Arkansas
🇺🇸Little Rock, Arkansas, United States
Cancer Center Oncology Medical Group
🇺🇸La Mesa, California, United States
UCLA
🇺🇸Los Angeles, California, United States
North County Oncology Medical Clinic
🇺🇸Oceanside, California, United States
The Jones Clinic, PC
🇺🇸Germantown, Tennessee, United States
Edmond Oncology Center
🇺🇸Edmond, Oklahoma, United States
Centro Oncológico Rosario
🇦🇷Rosario, Santa Fé, Argentina
ProCura - Centro Goiano de Pesquisa ClÃnica Ltda
🇧🇷Goiania, GO, Brazil
Associaçao Hospital de Caridade Ijui
🇧🇷Ijui, RS, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
🇧🇷Porto Alegre, Brazil
Centre de Sante et de Services Sociaux de Rimouski - Neigette
🇨🇦Rimouski, Quebec, Canada
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Vivantes Klinikum am Urban, Neztwerk fuer Gesundheit GmbH
🇩🇪Berlin, Germany
Szegedi Tudomanyegyetem, Urologiai Klinika
ðŸ‡ðŸ‡ºSzeged, Hungary
Struttura Complessa di Oncologia Medica Ospedale Santa Maria della Misericordia
🇮🇹Perugia, Italy
Szpital Kliniczny Przemienienia Panskiego UM im. Karola Marcinkowskiego w Poznaniu
🇵🇱Poznan, Poland
Hospital de San Joao
🇵🇹Porto, Portugal
Leningrad Regional Oncology Dispensary
🇷🇺Saint-Petersburg, Leningradskaya oblast, Russian Federation
Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia
🇷🇺Obninsk, Kaluga region, Russian Federation
Republican Clinical Oncology Dispensary of Minzdrav of Tatarstan Republic
🇷🇺Kazan, Russian Federation
Chair of Radiology and Radiotherapy
🇷🇺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
Moscow Scientific Research Oncology Institute P.A. Herzen
🇷🇺Moscow, Russian Federation
Privolzhskiy District Medical Center of Federal Biomedical Agency
🇷🇺Nizhni Novgorod, Russian Federation
Scientific research Institute of Oncology N.N. Petrov
🇷🇺Pesochny, Saint-Petersburg, Russian Federation
Institute for Oncology and Radiology of Serbia
🇷🇸Belgrade, Serbia
Clinical Center of Serbia
🇷🇸Belgrade, Serbia
Fakultna Nemocnica s poliklinikou F D Roosevelta
🇸🇰Banska Bystrica, Slovakia
Military Medical Academy
🇷🇸Belgrade, Serbia
Oddelenie funkcnej diagnostiky
🇸🇰Banska Bystrica, Slovakia
Klinika nuklearnej mediciny JLF UK a Martinskej fakultnej nemocnice
🇸🇰Martin, Slovakia
Institut Catala Doncologia
🇪🇸L'hospitalet de Llobregat, Barcelona, Spain
R.E.Kavetsky Institute of experimental pathology, oncology and radiobiology NAS of Ukraine,Laborator
🇺🇦Kiev, Ukraine
Southampton General Hospital
🇬🇧Southampton, Hampshire, United Kingdom
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil
Instituto de Oncologia de Piracicaba S/S Ltda
🇧🇷Piracicaba, SP, Brazil
Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie
🇵🇱Warszawa, Poland
Hospital de São João
🇵🇹Porto, Portugal
Klinika tuberkulozy a plucnych chorob UK JLF a Martinskej fakultnej nemocince
🇸🇰Martin, Slovakia
KK MED, s.r.o.
🇸🇰Zilina, Slovakia
Universitet, kafedra onkologyy
🇺🇦Chenivtsi, Ukraine
Donetske Obl. clinico-teritorial'ne medichne ob'yednannya
🇺🇦Donetsk, Ukraine
Oblasnyy onkologychnyy dispanser, onkourologichne viddilennya, Ivano-Frankivskiy Derzhavniy Medichni
🇺🇦Medychna vul., Ivano-Frankivsk, Ukraine
Orszagos Onkologiai Intezet
ðŸ‡ðŸ‡ºBudapest, Hungary
Tata Memorial Centre
🇮🇳Navi Mumbai, Maharashtra, India
Healthcare Global Enterprises Limited
🇮🇳Bangalore, Karnataka, India
Lakeshore Hospital & Research Center Limited
🇮🇳Kochi, Kerala, India
Wojskowy Instytut Medyczny, Pracownia Badan Cynnosciowych Ukladu Oddechowego, Klinika Chorob Wewnetr
🇵🇱Warszawa, Poland
Klinica nuklcarncj mediciny
🇸🇰Martin, Slovakia
MEDIVASA s.r.o.
🇸🇰Zilina, Slovakia
Panorama Medical Centre
🇿🇦Panorama, Cape Town, Western Cape, South Africa
Szpital Specjalistyczny im. L. Rydygiera Sp. z o.o.
🇵🇱Krakow, Poland
Centrum Medyczne Ostrobramska NZOZ "Magodent"
🇵🇱Warszawa, Poland
Jawaharlal Nehru Cancer Hospital, Department of Medical Oncology
🇮🇳Bhopal, Madhya Pradesh, India
Guy's Hospital
🇬🇧London, United Kingdom
Prince of Wales Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong