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

Renal Cell Carcinoma Clinical Trial

— INTORACT  

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

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

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

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

External Links

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