Clinical trial NCT01214720: A Study of Avastin (Bevacizumab) Added to a Chemotherapeutic Regimen in Patients With Metastatic Pancreatic Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-10-05
Enrollment: 607
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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Duration of Overall Survival - Percentage of Participants With an Event
timeFrame: Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized
measure: Duration of Overall Survival - Time to Event
timeFrame: Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized
Secondary outcomes:
measure: Clinical Benefit Response (CBR)
timeFrame: Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized
measure: Progression-Free Survival (PFS) - Percentage of Participants With an Event
timeFrame: Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression
measure: Progression-Free Survival (PFS) - Time to Event
timeFrame: Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression
measure: Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at First Postbaseline Tumor Assessment
timeFrame: Baseline and Week 8
measure: Bevacizumab Concentration in the Presence of Gemcitabine and Erlotinib
timeFrame: Weeks 1, 3, 5, 7, and 9
Other outcomes:
Locations:
city: Adelaide
country: Australia
city: Camperdown
country: Australia
city: Footscray
country: Australia
city: Heidelberg
country: Australia
city: Kurralta Park
country: Australia
city: Melbourne
country: Australia
city: Melbourne
country: Australia
city: St. Leonards
country: Australia
city: Sydney
country: Australia
city: Sydney
country: Australia
city: Graz
country: Austria
city: Innsbruck
country: Austria
city: Salzburg
country: Austria
city: Wien
country: Austria
city: Antwerpen
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Leuven
country: Belgium
city: Wilrijk
country: Belgium
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Beijing
country: China
city: Beijing
country: China
city: Shanghai
country: China
city: Brno
country: Czech Republic
city: Hradec Kralove
country: Czech Republic
city: Helsinki
country: Finland
city: Besancon
country: France
city: Bordeaux
country: France
city: Boulogne-billancourt
country: France
city: Clichy
country: France
city: Limoges
country: France
city: Marseille
country: France
city: Paris
country: France
city: Paris
country: France
city: Rouen
country: France
city: Saint Herblain
country: France
city: Strasbourg
country: France
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Bonn
country: Germany
city: Halle
country: Germany
city: Hamburg
country: Germany
city: Heidelberg
country: Germany
city: Leipzig
country: Germany
city: Magdeburg
country: Germany
city: Mainz
country: Germany
city: Muenchen
country: Germany
city: Mönchengladbach
country: Germany
city: Trier
country: Germany
city: Kfar Saba
country: Israel
city: Petach Tikva
country: Israel
city: Rehovot
country: Israel
city: Tel Aviv
country: Israel
city: Bergamo
country: Italy
city: Bologna
country: Italy
city: Brescia
country: Italy
city: Chieti
country: Italy
city: Genova
country: Italy
city: Napoli
country: Italy
city: Orbassano
country: Italy
city: Parma
country: Italy
city: San Giovanni Rotondo
country: Italy
city: Amsterdam
country: Netherlands
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Lima
country: Peru
city: Lima
country: Peru
city: Gliwice
country: Poland
city: Lublin
country: Poland
city: Szczecin
country: Poland
city: Wroclaw
country: Poland
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Cape Town
country: South Africa
city: Pretoria
country: South Africa
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Cordoba
country: Spain
city: Elche
country: Spain
city: Madrid
country: Spain
city: Santander
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Stockholm
country: Sweden
city: Kueishan
country: Taiwan
city: Taipei
country: Taiwan
city: Glasgow
country: United Kingdom
city: Leicester
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Northwood
country: United Kingdom
city: Sutton
country: United Kingdom
city: Truro
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: