Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects

NCT ID: NCT00631371

Last Updated: 2016-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 791 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2015-04-30

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.

Conditions

Renal Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

Bevacizumab 10 mg/kg intravenous (IV) q8wks

Temsirolimus

Intervention Type: DRUG

Temsirolimus 25 mg IV weekly

2

Bevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW

Group Type: ACTIVE_COMPARATOR

Bevacizumab

Intervention Type: DRUG

Bevacizumab 10 mg/kg intravenous (IV) q8wks

Interferon-Alfa 9MU

Intervention Type: DRUG

Interferon-Alfa 9MU SC TIW

Interventions

Bevacizumab

Bevacizumab 10 mg/kg intravenous (IV) q8wks

Intervention Type: DRUG

Temsirolimus

Temsirolimus 25 mg IV weekly

Intervention Type: DRUG

Bevacizumab

Bevacizumab 10 mg/kg intravenous (IV) q8wks

Intervention Type: DRUG

Interferon-Alfa 9MU

Interferon-Alfa 9MU SC TIW

Intervention Type: DRUG

Other Intervention Names

Torisel

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Hematology Oncology Services of Arkansas

Little Rock, Arkansas, United States

South County Hematology/Oncology

Chula Vista, California, United States

Cancer Center Oncology Medical Group

La Mesa, California, United States

UCLA Medical Center

Los Angeles, California, United States

UCLA

Los Angeles, California, United States

UCLA

Los Angeles, California, United States

North County Oncology Medical Clinic

Oceanside, California, 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

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 Jones Clinic, PC

New Albany, Mississippi, United States

The Cleveland Clinic

Cleveland, Ohio, United States

Edmond Oncology Center

Edmond, Oklahoma, 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

The Jones Clinic, PC

Germantown, Tennessee, United States

The Vanderbilt Clinic

Nashville, Tennessee, United States

University of Washington Medical Center

Seattle, Washington, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

Centro Oncológico Rosario

Rosario, Santa Fe Province, Argentina

ISIS Clinica Especializado

Santa Fe, Santa Fe Province, Argentina

Centro Medico San Roque

San Miguel de Tucumán, Tucumán Province, Argentina

Mater Adult Hospital

South Brisbane, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Ashford Cancer Center Research

Kurralta Park, South Australia, Australia

Cancer Care SA

Kurralta Park, , Australia

Mater Private Hospital

South Brisbane, , Australia

ZNA Middelheim

Antwerp, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

Jessa Ziekenhuis - campus Virga Jessa

Hasselt, , Belgium

Cliniques Universitaires de Mont-Godinne UCL

Mont-Godinne, , Belgium

Centro Goiano de Oncologia

Goiânia, Goiás, Brazil

Centro Goiano de Oncologia - CGO

Goiânia, Goiás, Brazil

ProCura - Centro Goiano de Pesquisa Clínica Ltda

Goiânia, Goiás, Brazil

Instituto Nacional de Cancer - INCA

Rio de Janeiro, Rio de Janeiro, Brazil

Instituto Nacional do Cancer - INCA

Rio de Janeiro, Rio de Janeiro, Brazil

Associaçao Hospital de Caridade Ijui

Ijuí, Rio Grande do Sul, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Clinica de Oncologia de Porto Alegre - Sociedade Simples Ltda.

Porto Alegre, Rio Grande do Sul, Brazil

Clínica de Oncologia de Porto Alegre Sociedade Simples Ltda

Porto Alegre, Rio Grande do Sul, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil

Instituto de Oncologia de Piracicaba S/S Ltda

Piracicaba, São Paulo, Brazil

Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira - ICESP

São Paulo, São Paulo, Brazil

Irmandade da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, , Brazil

Odette Cancer Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Centre de Sante et de Services Sociaux de Rimouski - Neigette

Rimouski, Quebec, Canada

Instituto Clinico Oncologico del Sur

Santiago, Chile, Chile

Instituto Nacional del Cancer

Santiago, Region Metropolitana / Chile, Chile

Fundacion Arturo Lopez Perez

Santiago, , Chile

Oncologos del Occidente S.A

Pereira, Risaralda Department, Colombia

Oblastni nemocnice Jicin a s

Jičín, Ceska Republika, Czechia

Masarykuv onkologicky ustav

Brno, , Czechia

Fakultni nemocnice Olomouc

Olomouc, , Czechia

Krajska zdravotni, a.s.

Ústí nad Labem, , Czechia

Centre Jean Perrin

Clermont-Ferrand, , France

Clinique Sainte Marguerite

Hyères, , France

Hopital Andre Mignot

Le Chesnay, , France

Centre médical Oncogard

Nîmes, , France

CHU de Poitiers

Poitiers, , France

CHU de Rouen

Rouen, , France

Centre rené Gauducheau

Saint-Herblain-Nantes, , France

Hopital Foch

Suresnes, , France

Institut Gustave Roussy

Villejuif, , France

Vivantes Klinikum am Urban, Neztwerk fuer Gesundheit GmbH

Berlin, , Germany

Universitaetsklinikum Hamburg Eppendorf

Hamburg, , Germany

Klinikum Region Hannover, Krankenhaus Siloah

Hanover, , Germany

TU Muenchen, rechts der Isar

München, , 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, , Hungary

Uzsoki Utcai Korhaz

Budapest, , Hungary

Petz Aladar Megyei Oktato Korhaz

Győr, , Hungary

Josa Andras Oktato Korhaz Nonprofit Kft.

Nyíregyháza, , Hungary

Szegedi Tudomanyegyetem, Urologiai Klinika

Szeged, , Hungary

Veszprem Megyei Csolnoky Ferenc

Veszprém, , Hungary

Vedanta Institute of Medical Sciences

Ahmedabad, Gujarat, India

Healthcare Global Enterprises Limited

Bangalore, Karnataka, India

Lakeshore Hospital & Research Center Limited

Kochi, Kerala, India

Jawaharlal Nehru Cancer Hospital, Department of Medical Oncology

Bhopal, Madhya Pradesh, India

Tata Memorial Center

Mumbai, Maharashtra, India

Tata Memorial Centre

Navi Mumbai, Maharashtra, India

Jehangir Hospital

Pune, Maharashtra, India

Searoc Cancer Centre

Jaipur, Rajasthan, India

Apollo Hospital

Chennai, Tamil Nadu, India

Regional Cancer Centre

Kerela, Trivandrum, India

Divisione di Urologia, Azienda Ospedaliera Policlinico Consorziale di Bari

Bari, , Italy

Sezione di Oncologia Medica Centro di Ricerca Clinica

Chieti, , Italy

Unità Operativa di Oncologia, Azienda Ospedaliera Policlinico di Modena

Modena, , Italy

Farmacia del Comitato Etico Provinciale 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, , Italy

University Malaya Medical Centre

Kuala Lumpur, Malaysia, Malaysia

Hospital Aranda de la Parra

León, Guanajuato, Mexico

Spaarne Ziekenhuis

Hoofddorp, , Netherlands

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 Onkologii, Instytut im. M. Sklodowskiej-Curie

Warsaw, , Poland

Centrum Medyczne Ostrobramska NZOZ "Magodent"

Warsaw, , Poland

Wojskowy Instytut Medyczny, Pracownia Badan Cynnosciowych Ukladu Oddechowego, Klinika Chorob Wewnetr

Warsaw, , Poland

Wojskowy Intsytut Medyczny, Zaklad Diagnostyki Laboratoryjnej CSK MON

Warsaw, , Poland

Wojskowy Intsytut Medyczny, Zaklad Medycyny Nuklearnej CSK MON

Warsaw, , Poland

Hospital de San Joao

Porto, , Portugal

Hospital de São João

Porto, , Portugal

Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia

Obninsk, Kaluga Oblast, Russia

Leningrad Regional Oncology Dispensary

Saint-Petersburg, Leningradskaya Oblast', Russia

Republican Clinical Oncology Dispensary of Minzdrav of Tatarstan Republic

Kazan', , Russia

Chair of Radiology and Radiotherapy

Moscow, , Russia

N.N. Blokhin Russian Cancer Research Center, Department of Clinical Pharmacology and Chemotherapy

Moscow, , Russia

N.N. Blokhin Russian Cancer Research Center, Department of Urology

Moscow, , Russia

Moscow Scientific Research Oncology Institute P.A. Herzen

Moscow, , Russia

Privolzhskiy District Medical Center of Federal Biomedical Agency

Nizhny Novgorod, , Russia

Scientific research Institute of Oncology N.N. Petrov

Pesochny, Saint-Petersburg, , Russia

City Hospital No.26

Saint Petersburg, , Russia

City Pokrovskaya Hospital

Saint Petersburg, , Russia

Clinical Center of Serbia

Belgrade, , Serbia

Institute for Oncology and Radiology of Serbia

Belgrade, , Serbia

Military Medical Academy

Belgrade, , Serbia

National Cancer Centre Singapore

Singapore, , Singapore

Fakultna Nemocnica s poliklinikou F D Roosevelta

Banská Bystrica, , Slovakia

Oddelenie funkcnej diagnostiky

Banská Bystrica, , Slovakia

Klinika pneumologie a ftiziologie FNsP LFUK

Bratislava, , Slovakia

Fakultna Nemocnica s poliklinikou akad L Derera

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.

Žilina, , Slovakia

MEDIVASA s.r.o.

Žilina, , Slovakia

Nemocnica s poliklinikou Zilina

Žilina, , Slovakia

GVI Oncology Trial Unit

Kraaifontein, Cape Town, South Africa

Westridge Medical Centre

Mayville, Durban, South Africa

Pretoria Urology Hospital

Hatfield, Pretoria, 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, , South Africa

Samsung Medical Center

Seoul, Korea, South Korea

Yonsei University Health System-Severance Hospital

Seoul, , South Korea

Hospital Sant Creu I Sant Pau

Barcelona, Barcelona, Spain

Institut Catala Doncologia

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Hospital de Madrid Norte-Sanchinarro

Madrid, Madrid, Spain

Hospital del mar de Barcelona

Barcelona, , Spain

Instituto Valenciano de Oncología

Valencia, , Spain

Veterans General Hospital-Taipei

Taipei, ROC, Taiwan

National Taiwan University Hospital

Taipei TOC, Taiwan, Taiwan

Tri-Service General Hospital

Neihu District, Tapei, Taiwan

China Medical University Hospital

Taichung, , Taiwan

Division of Oncology

Taoyuan District, , Taiwan

Universitet, kafedra onkologyy

Chenivtsi, , Ukraine

A.P Romodanov Itstitut nejrohirurhii

Chernivtsi, , Ukraine

Uchbobo-naukovyi likuvalnyi kompleks DDMU im. M.Gor'kogo

Donetsk, , Ukraine

Donetskyy Oblasyy protypukhlynnyy Tsenter

Donetsk, , Ukraine

Donetske Obl. clinico-teritorial'ne medichne ob'yednannya

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, , Ukraine

Southampton General Hospital

Southampton, Hampshire, United Kingdom

Christie Hospital

Withington, Manchester, United Kingdom

University of Leeds

Leeds, North Yorkshire, United Kingdom

Guy's Hospital

London, , United Kingdom

Countries

United States; Argentina; Australia; Belgium; Brazil; Canada; Chile; Colombia; Czechia; France; Germany; Hong Kong; Hungary; India; Italy; Malaysia; Mexico; Netherlands; Poland; Portugal; Russia; Serbia; Singapore; Slovakia; South Africa; South Korea; Spain; Taiwan; Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 37146227 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28410911 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27238653 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24297945 (View on PubMed)

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3066K1-3311&StudyName=Study%20Comparing%20Bevacizumab%20+%20Temsirolimus%20vs.%20Bevacizumab%20+%20Interferon-Alfa%20In%20Advanced%20Renal%20Cell%20Carcinoma%20Subjects

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Other Identifiers

B1771006

Identifier Type: OTHER

Identifier Source: secondary_id

2007-003793-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3066K1-3311

Identifier Type: -

Identifier Source: org_study_id