Trial information
A Study of Avastin (Bevacizumab) Added to a Chemotherapeutic Regimen in Patients With Metastatic Pancreatic Cancer
Status: Completed
Protocol number: BO17706
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind study of the effect of Avastin plus gemcitabine and erlotinib compared with placebo plus gemcitabine and erlotinib on overall survival in patients with metastatic pancreatic cancer
Brief summary: This study will evaluate efficacy, safety and tolerability of Avastin versus placebo added to a chemotherapeutic regimen in patients with metastatic pancreatic cancer. The anticipated time of study treatment is until confirmed evidence of disease progression, and the target sample size is 500+ individuals.
Target sample size is 600.
Study phase: III
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
Condition: Pancreatic Cancer
Intervention type: Drug
Intervention name: bevacizumab[Avastin]
Primary outcome: 1. Overall survival
Key secondary outcomes: 1. Efficacy: Tumor assessment, progression-free survival and clinical benefit response rate.
Safety: Hematology, coagulation, blood chemistry, and urinalysis.
Inclusion criteria:
- adult patients, >=18 years of age;
- metastatic pancreatic cancer (adenocarcinoma);
- good liver, kidney, and bone marrow function.
Exclusion criteria:
- previous systemic treatment for metastatic pancreatic cancer;
- pregnant or lactating females;
- fertile men, or women of childbearing potential, not using adequate contraception;
- major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start;
- current or recent treatment (within 30 days prior to starting study treatment) with another investigational drug, or participation in another investigational study.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: July, 2005
Trial registration date: 06/24/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Australia
- Adelaide
- Heidelberg
- Melbourne
- St. Leonards
- Sydney
Austria
Belgium
- Antwerpen
- Bruxelles
- Leuven
- Wilrijk
Canada
- Edmonton, AB
- Vancouver, BC
- Ottawa, ON
- Toronto, ON
- Montreal, QC
- Quebec City, QC
China
Czech Republic
Finland
France
- Besancon
- Bordeaux
- Boulogne-Billancourt
- Clichy
- Limoges
- Marseille
- Paris
- Saint Herblain
- Strasbourg
Germany
- Berlin
- Bochum
- Bonn
- Hamburg
- Heidelberg
- Leipzig
- Magdeburg
- Mainz
- München
- Münchengladbach
- Trier
- Ulm
Israel
- Kfar Saba
- Petah Tikva
- Rehovot
- Tel Aviv
Italy
- Bologna
- Chieti
- Genova
- Napoli
- Orbassano
- Parma
- San Giovanni Rotondo
Netherlands
New Zealand
Peru
Poland
- Gliwice
- Lublin
- Szczecin
- Wroclaw
Singapore
South Africa
Spain
- Alicante
- Barcelona
- Elche
- Madrid
- Santander
- Valencia
Sweden
Taiwan
United Kingdom
- Glasgow
- Leicester
- Manchester
- Northwood
- Sutton
- Truro
