Trial information
A Study of Avastin (Bevacizumab) Added to Interferon Alfa-2a (Roferon) Therapy in Patients With Metastatic Renal Cell Cancer With Nephrectomy
Status: No longer recruiting
Protocol number: BO17705
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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
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 patients 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 500+ individuals.
Target sample size is
638.
Study phase: III
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
Condition: Renal Cell Cancer
Intervention type: Drug
Intervention name: bevacizumab [Avastin]
Primary outcome: 1. Overall survival.
Time frame: Week 52
Key secondary outcomes: 1. Efficacy: Progression-free survival, time to disease progression, time to treatment failure, objective response rates. Safety: Hematology, serum chemistry, urinalysis, and adverse events.
Time frame: Throughout study
Inclusion criteria:
- adult patients;
- >=18 years of age;
- 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;
- ongoing need for full dose anticoagulants;
- uncontrolled hypertension;
- clinically significant cardiovascular disease.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: June, 2004
Trial registration date: 06/24/2005
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Australia
- Adelaide
- Brisbane
- Canberra
- Frankston
- Melbourne
- Perth
- Sydney
Belgium
- Antwerpen
- Bruxelles
- Wilrijk
Czech Republic
- Ceské Budejovice
- Chomutov
- Hradec Kralove
Finland
France
- Angers
- Bordeaux
- Caen
- Clermont-Ferrand
- Grenoble
- Lille
- Limoges
- Lyon
- Marseille
- Nice
- Poitiers
- Saint Herblain
- Strasbourg
- Suresnes
- Toulouse
- Villejuif
Germany
- Berlin
- Darmstadt
- Hamburg
- Hannover
- Mannheim
- Marburg
- München
- Planegg
Hungary
Israel
- Holon
- Ramat Gan
- Rehovot
- Tel Aviv
- Zerifin
Italy
- Livorno
- Milano
- Modena
- Napoli
- Perugia
- Roma
- Rozzano
- Torino
Netherlands
Norway
- Ålesund
- Oslo
- Stavanger
- Trondheim
Poland
- Bydgoszcz
- Krakow
- Lodz
- Olsztyn
- Tarnow
- Warszawa
Russian Federation
- Moscow
- Obninsk
- St Petersburg
Singapore
Spain
- Barcelona
- Madrid
- Malaga
- Pontevedra
- Santander
- Valencia
- Zaragoza
Switzerland
Taiwan
- Chang Gung
- Kaohsiung
- Taichung
- Taipei
United Kingdom
