Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects
INTORACT
Phase 3b, Randomized, Open-Label Study Of Bevacizumab + Temsirolimus Vs. Bevacizumab + Interferon-Alfa As First-Line Treatment In Subjects With Advanced Renal Cell Carcinoma
3 other identifiers
interventional
791
30 countries
172
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2008
Longer than P75 for phase_3
172 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2008
CompletedFirst Posted
Study publicly available on registry
March 7, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedResults Posted
Study results publicly available
June 4, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedApril 27, 2016
March 1, 2016
4 years
February 28, 2008
April 18, 2013
March 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (3)
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)
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)
Overall Survival (OS)
Baseline until death due to any cause, assessed every 8 weeks (up to cut-off date: 19 April 2012)
Study Arms (2)
1
EXPERIMENTALBevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly
2
ACTIVE COMPARATORBevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Prior systemic treatment for RCC
- Evidence of current or prior central nervous system (CNS) metastases
- Cardiovascular disease
- Pregnant or nursing women
- Additional criteria applies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (172)
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, 72205, United States
South County Hematology/Oncology
Chula Vista, California, 91911, United States
Cancer Center Oncology Medical Group
La Mesa, California, 91942, United States
UCLA Medical Center
Los Angeles, California, 90095-1694, United States
UCLA
Los Angeles, California, 90095-6984, United States
UCLA
Los Angeles, California, 90095, United States
North County Oncology Medical Clinic
Oceanside, California, 92056, United States
Medical Oncology Associates - SD
San Diego, California, 92123, United States
Sharp Memorial Hospital Investigational Pharmacy
San Diego, California, 92123, United States
Sharp Rees-Stealy
San Diego, California, 92123, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
Pacific Hematology/Oncology Associates
San Francisco, California, 94115, United States
San Francisco Oncology Associates
San Francisco, California, 94115, United States
Cohen & Hufford MD's INC
San Francisco, California, 94118, United States
The Jones Clinic, PC
New Albany, Mississippi, 38652, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
Edmond Oncology Center
Edmond, Oklahoma, 73034, United States
OU Medical Center
Oklahoma City, Oklahoma, 73104, United States
OU Physician's Building
Oklahoma City, Oklahoma, 73104, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
The Jones Clinic, PC
Germantown, Tennessee, 38138, United States
The Vanderbilt Clinic
Nashville, Tennessee, 37232, United States
University of Washington Medical Center
Seattle, Washington, 96195, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023, United States
Centro OncolĂłgico Rosario
Rosario, Santa Fe Province, S2000KZE, Argentina
ISIS Clinica Especializado
Santa Fe, Santa Fe Province, 3000, Argentina
Centro Medico San Roque
San Miguel de Tucumán, Tucumán Province, T4000IAK, Argentina
Mater Adult Hospital
South Brisbane, Queensland, 4101, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Ashford Cancer Center Research
Kurralta Park, South Australia, 5037, Australia
Cancer Care SA
Kurralta Park, 5037, Australia
Mater Private Hospital
South Brisbane, QLD 4101, Australia
ZNA Middelheim
Antwerp, 2020, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Jessa Ziekenhuis - campus Virga Jessa
Hasselt, 3500, Belgium
Cliniques Universitaires de Mont-Godinne UCL
Mont-Godinne, 5530, Belgium
Centro Goiano de Oncologia
Goiânia, Goiás, 74075-040, Brazil
Centro Goiano de Oncologia - CGO
Goiânia, Goiás, 74130-015, Brazil
ProCura - Centro Goiano de Pesquisa ClĂnica Ltda
Goiânia, Goiás, 74140-050, Brazil
Instituto Nacional de Cancer - INCA
Rio de Janeiro, Rio de Janeiro, 20230-130, Brazil
Instituto Nacional do Cancer - INCA
Rio de Janeiro, Rio de Janeiro, 20231-050, Brazil
Associaçao Hospital de Caridade Ijui
IjuĂ, Rio Grande do Sul, 98700-000, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Clinica de Oncologia de Porto Alegre - Sociedade Simples Ltda.
Porto Alegre, Rio Grande do Sul, 90430-090, Brazil
ClĂnica de Oncologia de Porto Alegre Sociedade Simples Ltda
Porto Alegre, Rio Grande do Sul, 90430-090, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, SĂŁo Paulo, 14784-400, Brazil
Instituto de Oncologia de Piracicaba S/S Ltda
Piracicaba, SĂŁo Paulo, 13419-155, Brazil
Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira - ICESP
SĂŁo Paulo, SĂŁo Paulo, 01246-000, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90050-170, Brazil
Odette Cancer Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Centre de Sante et de Services Sociaux de Rimouski - Neigette
Rimouski, Quebec, G5L 5T1, Canada
Instituto Clinico Oncologico del Sur
Santiago, Chile, Chile
Instituto Nacional del Cancer
Santiago, Region Metropolitana / Chile, 8380455, Chile
Fundacion Arturo Lopez Perez
Santiago, Chile
Oncologos del Occidente S.A
Pereira, Risaralda Department, Colombia
Oblastni nemocnice Jicin a s
JiÄŤĂn, Ceska Republika, 506 43, Czechia
Masarykuv onkologicky ustav
Brno, 656 53, Czechia
Fakultni nemocnice Olomouc
Olomouc, 775 20, Czechia
Krajska zdravotni, a.s.
ĂšstĂ nad Labem, 401 13, Czechia
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Clinique Sainte Marguerite
Hyères, 83400, France
Hopital Andre Mignot
Le Chesnay, 78157, France
Centre médical Oncogard
Nîmes, 30907, France
CHU de Poitiers
Poitiers, 86021, France
CHU de Rouen
Rouen, 76031, France
Centre rené Gauducheau
Saint-Herblain-Nantes, 44805, France
Hopital Foch
Suresnes, 92151, France
Institut Gustave Roussy
Villejuif, 94805, France
Vivantes Klinikum am Urban, Neztwerk fuer Gesundheit GmbH
Berlin, 10967, Germany
Universitaetsklinikum Hamburg Eppendorf
Hamburg, 20246, Germany
Klinikum Region Hannover, Krankenhaus Siloah
Hanover, 30449, Germany
TU Muenchen, rechts der Isar
MĂĽnchen, 81675, Germany
Prince of Wales Hospital
Hong Kong, Hong Kong, Hong Kong
Pamela Youde Nethersole Eastern Hospital
Chai Wan, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Orszagos Onkologiai Intezet
Budapest, 1122, Hungary
Uzsoki Utcai Korhaz
Budapest, 1145, Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, 9024, Hungary
Josa Andras Oktato Korhaz Nonprofit Kft.
NyĂregyháza, 4400, Hungary
Szegedi Tudomanyegyetem, Urologiai Klinika
Szeged, 6725, Hungary
Veszprem Megyei Csolnoky Ferenc
Veszprém, 8200, Hungary
Vedanta Institute of Medical Sciences
Ahmedabad, Gujarat, 380009, India
Healthcare Global Enterprises Limited
Bangalore, Karnataka, 560027, India
Lakeshore Hospital & Research Center Limited
Kochi, Kerala, 682304, India
Jawaharlal Nehru Cancer Hospital, Department of Medical Oncology
Bhopal, Madhya Pradesh, 462001, India
Tata Memorial Center
Mumbai, Maharashtra, 400012, India
Tata Memorial Centre
Navi Mumbai, Maharashtra, 410210, India
Jehangir Hospital
Pune, Maharashtra, 411001, India
Searoc Cancer Centre
Jaipur, Rajasthan, 302013, India
Apollo Hospital
Chennai, Tamil Nadu, 600035, India
Regional Cancer Centre
Kerela, Trivandrum, 695011, India
Divisione di Urologia, Azienda Ospedaliera Policlinico Consorziale di Bari
Bari, 70124, Italy
Sezione di Oncologia Medica Centro di Ricerca Clinica
Chieti, 66013, Italy
UnitĂ Operativa di Oncologia, Azienda Ospedaliera Policlinico di Modena
Modena, 41100, Italy
Farmacia del Comitato Etico Provinciale di Modena
Modena, 41124, Italy
Struttura Complessa di Oncologia Medica Ospedale Santa Maria della Misericordia
Perugia, 06132, Italy
IFO- Istituti Fisioterapici Ospitalieri
Roma, 00144, Italy
Azienda Ospedaliera S. Maria
Terni, 05100, Italy
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100, Malaysia
Hospital Aranda de la Parra
LeĂłn, Guanajuato, 37000, Mexico
Spaarne Ziekenhuis
Hoofddorp, 2134 TM, Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, 80952, Poland
Szpital Specjalistyczny im. L. Rydygiera Sp. z o.o.
Krakow, 31-826, Poland
Centrum Onkologii Ziemi Lubelskiej im. sw Jana z Dukli
Lublin, 20-090, Poland
Szpital Kliniczny Przemienienia Panskiego UM im. Karola Marcinkowskiego w Poznaniu
Poznan, 60-569, Poland
Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie
Warsaw, 02-781, Poland
Centrum Medyczne Ostrobramska NZOZ "Magodent"
Warsaw, 04-125, Poland
Wojskowy Instytut Medyczny, Pracownia Badan Cynnosciowych Ukladu Oddechowego, Klinika Chorob Wewnetr
Warsaw, 04-141, Poland
Wojskowy Intsytut Medyczny, Zaklad Diagnostyki Laboratoryjnej CSK MON
Warsaw, 04-141, Poland
Wojskowy Intsytut Medyczny, Zaklad Medycyny Nuklearnej CSK MON
Warsaw, 04-141, Poland
Hospital de San Joao
Porto, 4200-319, Portugal
Hospital de SĂŁo JoĂŁo
Porto, 4200-319, Portugal
Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia
Obninsk, Kaluga Oblast, 249036, Russia
Leningrad Regional Oncology Dispensary
Saint-Petersburg, Leningradskaya Oblast', 188663, Russia
Republican Clinical Oncology Dispensary of Minzdrav of Tatarstan Republic
Kazan', 420029, Russia
Chair of Radiology and Radiotherapy
Moscow, 105077, Russia
N.N. Blokhin Russian Cancer Research Center, Department of Clinical Pharmacology and Chemotherapy
Moscow, 115478, Russia
N.N. Blokhin Russian Cancer Research Center, Department of Urology
Moscow, 115478, Russia
Moscow Scientific Research Oncology Institute P.A. Herzen
Moscow, 125284, Russia
Privolzhskiy District Medical Center of Federal Biomedical Agency
Nizhny Novgorod, 603109, Russia
Scientific research Institute of Oncology N.N. Petrov
Pesochny, Saint-Petersburg, 197758, Russia
City Hospital No.26
Saint Petersburg, 196247, Russia
City Pokrovskaya Hospital
Saint Petersburg, 199106, Russia
Clinical Center of Serbia
Belgrade, 11000, Serbia
Institute for Oncology and Radiology of Serbia
Belgrade, 11000, Serbia
Military Medical Academy
Belgrade, 11000, Serbia
National Cancer Centre Singapore
Singapore, 169610, Singapore
Fakultna Nemocnica s poliklinikou F D Roosevelta
Banská Bystrica, 974 01, Slovakia
Oddelenie funkcnej diagnostiky
Banská Bystrica, 974 01, Slovakia
Klinika pneumologie a ftiziologie FNsP LFUK
Bratislava, 826 06, Slovakia
Fakultna Nemocnica s poliklinikou akad L Derera
Bratislava, 833 05, Slovakia
Klinica nuklcarncj mediciny
Martin, 036 59, Slovakia
Klinika nuklearnej mediciny JLF UK a Martinskej fakultnej nemocnice
Martin, 036 59, Slovakia
Klinika tuberkulozy a plucnych chorob UK JLF a Martinskej fakultnej nemocince
Martin, 036 59, Slovakia
Nemocnica s poliklinikou Skalica
Skalica, 909 82, Slovakia
KK MED, s.r.o.
Žilina, 012 07, Slovakia
MEDIVASA s.r.o.
Žilina, 012 07, Slovakia
Nemocnica s poliklinikou Zilina
Žilina, 012 07, Slovakia
GVI Oncology Trial Unit
Kraaifontein, Cape Town, 7570, South Africa
Westridge Medical Centre
Mayville, Durban, 4001, South Africa
Pretoria Urology Hospital
Hatfield, Pretoria, 0083, South Africa
Panorama Medical Centre
Panorama, Cape Town, Western Cape, 7500, South Africa
University of the Witwatersrand Oncology
Parktown, 2193, South Africa
Langenhoven Drive Oncology Centre
Port Elizabeth, 6006, South Africa
Dr. Fourie & Voges
Pretoria, 0084, South Africa
Samsung Medical Center
Seoul, Korea, 135-710, South Korea
Yonsei University Health System-Severance Hospital
Seoul, 120-752, South Korea
Hospital Sant Creu I Sant Pau
Barcelona, Barcelona, 08025, Spain
Institut Catala Doncologia
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital de Madrid Norte-Sanchinarro
Madrid, Madrid, 28050, Spain
Hospital del mar de Barcelona
Barcelona, 8003, Spain
Instituto Valenciano de OncologĂa
Valencia, 46009, Spain
Veterans General Hospital-Taipei
Taipei, ROC, 11217, Taiwan
National Taiwan University Hospital
Taipei TOC, Taiwan, 100, Taiwan
Tri-Service General Hospital
Neihu District, Tapei, 114, Taiwan
China Medical University Hospital
Taichung, 404, Taiwan
Division of Oncology
Taoyuan District, 333, Taiwan
Universitet, kafedra onkologyy
Chenivtsi, 58013, Ukraine
A.P Romodanov Itstitut nejrohirurhii
Chernivtsi, 58001, Ukraine
Uchbobo-naukovyi likuvalnyi kompleks DDMU im. M.Gor'kogo
Donetsk, 83003, Ukraine
Donetskyy Oblasyy protypukhlynnyy Tsenter
Donetsk, 83092, Ukraine
Donetske Obl. clinico-teritorial'ne medichne ob'yednannya
Donetsk, 83099, Ukraine
"State Institution ""Institute for Occupational Health of the
Kiev, 01033, Ukraine
R.E.Kavetsky Institute of experimental pathology, oncology and radiobiology NAS of Ukraine,Laborator
Kiev, 03115, Ukraine
A.P Romodanov Itstitut nejrohirurhii
Kiyv, 04050, Ukraine
Oblasnyy onkologychnyy dispanser, onkourologichne viddilennya, Ivano-Frankivskiy Derzhavniy Medichni
Medychna Vul., Ivano-Frankivsk, 76018, Ukraine
Southampton General Hospital
Southampton, Hampshire, SO16 6YD, United Kingdom
Christie Hospital
Withington, Manchester, M20 4BX, United Kingdom
University of Leeds
Leeds, North Yorkshire, LS9 7TF, United Kingdom
Guy's Hospital
London, SE1 7EH, United Kingdom
Related Publications (4)
Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.
PMID: 37146227DERIVEDde 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.
PMID: 28410911DERIVEDGrunwald 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.
PMID: 27238653DERIVEDRini 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.
PMID: 24297945DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2008
First Posted
March 7, 2008
Study Start
April 1, 2008
Primary Completion
April 1, 2012
Study Completion
April 1, 2015
Last Updated
April 27, 2016
Results First Posted
June 4, 2013
Record last verified: 2016-03