Clinical trial NCT00738530: A Study of Avastin (Bevacizumab) Added to Interferon Alfa-2a (Roferon) Therapy in Patients With Metastatic Renal Cell Cancer With Nephrectomy
Official title: A Randomised, Double-blind Study to Evaluate the Efficacy and Safety of Avastin Plus Roferon Compared With Placebo Plus Roferon on Overall Survival and Tumor Assessment in Nephrectomised Patients With Metastatic Clear Cell Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Cell Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-08-20
Enrollment: 649
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in combination with Roferon as first-line treatment in participants with metastatic renal cell cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is 1-2 years, and the target sample size is greater than (\>)500 individuals.


Eligibility criteria: Inclusion Criteria:

* metastatic renal cell cancer (clear cell type);
* nephrectomy;
* absence of proteinuria.

Exclusion Criteria:

* prior systemic treatment for metastatic renal cell cancer;
* major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start;
* presence of brain metastases or spinal cord compression;
* ongoing need for full dose anticoagulants;
* uncontrolled hypertension;
* clinically significant cardiovascular disease.

Primary outcomes:
measure: Percentage of Participants Who Died
timeFrame: Baseline up to 4.25 years
measure: Overall Survival (OS) Duration
timeFrame: Baseline until death (up to 4.25 years)
Secondary outcomes:
measure: Percentage of Participants With Disease Progression or Death
timeFrame: Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
measure: Progression Free Survival (PFS) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
timeFrame: Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
measure: Time to Progression (TTP) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
timeFrame: Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
measure: Percentage of Participants With Treatment Failure
timeFrame: Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
measure: Time to Treatment Failure (TTF) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
timeFrame: Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
measure: Percentage of Participants With Objective Response According to mRECIST
timeFrame: Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
measure: Percentage of Participants With Best Overall Response According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
timeFrame: Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)
measure: Change From Baseline in Karnofsky Performance Status
timeFrame: Baseline, Week 7, 15, 23, 31, 43
Other outcomes:
Locations:
city: Adelaide
country: Australia
city: Adelaide
country: Australia
city: Brisbane
country: Australia
city: Canberra
country: Australia
city: Frankston
country: Australia
city: Kurralta Park
country: Australia
city: Melbourne
country: Australia
city: Perth
country: Australia
city: Sydney
country: Australia
city: Sydney
country: Australia
city: Antwerpen
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Wilrijk
country: Belgium
city: Ceské Budejovice
country: Czech Republic
city: Chomutov
country: Czech Republic
city: Hradec Kralove
country: Czech Republic
city: Plzen
country: Czech Republic
city: Tampere
country: Finland
city: Turku
country: Finland
city: Angers
country: France
city: Bordeaux
country: France
city: Caen
country: France
city: Clermont Ferrand
country: France
city: Grenoble
country: France
city: Lille
country: France
city: Limoges
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Nice
country: France
city: Poitiers
country: France
city: Saint Herblain
country: France
city: Strasbourg
country: France
city: Suresnes
country: France
city: Toulouse
country: France
city: Villejuif
country: France
city: Berlin
country: Germany
city: Darmstadt
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Mannheim
country: Germany
city: Marburg
country: Germany
city: München
country: Germany
city: Planegg
country: Germany
city: Budapest
country: Hungary
city: Szombathely
country: Hungary
city: Holon
country: Israel
city: Ramat-gan
country: Israel
city: Rehovot
country: Israel
city: Tel Aviv
country: Israel
city: Zerifin
country: Israel
city: Livorno
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Modena
country: Italy
city: Napoli
country: Italy
city: Perugia
country: Italy
city: Roma
country: Italy
city: Rozzano
country: Italy
city: Torino
country: Italy
city: Amsterdam
country: Netherlands
city: Nijmegen
country: Netherlands
city: Oslo
country: Norway
city: Stavanger
country: Norway
city: Trondheim
country: Norway
city: Ålesund
country: Norway
city: Bydgoszcz
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Olsztyn
country: Poland
city: Tarnow
country: Poland
city: Warszawa
country: Poland
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Obninsk
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Granada
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Málaga
country: Spain
city: Pontevedra
country: Spain
city: Santander
country: Spain
city: Valencia
country: Spain
city: Zaragoza
country: Spain
city: Basel
country: Switzerland
city: Bern
country: Switzerland
city: Geneve
country: Switzerland
city: Chang Gung
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: