A Study of Avastin (Bevacizumab) Added to a Chemotherapeutic Regimen in Patients With Metastatic Pancreatic Cancer
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
1 other identifier
interventional
607
20 countries
91
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pancreatic-cancer
Started Jul 2005
91 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 4, 2010
CompletedFirst Posted
Study publicly available on registry
October 5, 2010
CompletedResults Posted
Study results publicly available
August 13, 2014
CompletedAugust 13, 2014
July 1, 2014
3.3 years
October 4, 2010
July 23, 2014
July 23, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Duration of Overall Survival - Percentage of Participants With an Event
Duration of overall survival (OS) was defined as the time between date of randomization and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization.
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
Duration of Overall Survival - Time to Event
Duration of OS was defined as the time between date of randomization and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization. Median duration of survival was estimated using the Kaplan-Meier method.
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 (5)
Clinical Benefit Response (CBR)
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
Progression-Free Survival (PFS) - Percentage of Participants With an Event
Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression
Progression-Free Survival (PFS) - Time to Event
Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression
Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at First Postbaseline Tumor Assessment
Baseline and Week 8
Bevacizumab Concentration in the Presence of Gemcitabine and Erlotinib
Weeks 1, 3, 5, 7, and 9
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age;
- metastatic pancreatic cancer (adenocarcinoma);
- good liver, kidney, and bone marrow function.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (101)
Unknown Facility
Adelaide, 5011, Australia
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Camperdown, 2050, Australia
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Footscray, 3011, Australia
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Heidelberg, 3084, Australia
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Kurralta Park, 5037, Australia
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Melbourne, 3002, Australia
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Melbourne, 3128, Australia
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St Leonards, 2065, Australia
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Sydney, 2031, Australia
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Sydney, 2217, Australia
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Salzburg, 5020, Austria
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Vienna, 1090, Austria
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Antwerp, 2020, Belgium
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Brussels, 1070, Belgium
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Brussels, 1200, Belgium
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Leuven, 3000, Belgium
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Wilrijk, 2610, Belgium
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Edmonton, Alberta, T6G 1Z2, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H2W 1S6, Canada
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Québec, Quebec, G1R 2J6, Canada
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Beijing, 100036, China
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Beijing, 100071, China
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Shanghai, 200433, China
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Brno, 656 53, Czechia
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Hradec Králové, 500 05, Czechia
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Helsinki, 00029, Finland
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Besançon, 25030, France
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Bordeaux, 33000, France
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Boulogne-Billancourt, 92104, France
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Clichy, 92118, France
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Limoges, 87042, France
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Marseille, 13273, France
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Paris, 75674, France
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Paris, 75679, France
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Rouen, 76031, France
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Saint-Herblain, 44805, France
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Strasbourg, 67091, France
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Berlin, 13353, Germany
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Bochum, 44892, Germany
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Bonn, 53127, Germany
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Halle, 06120, Germany
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Hamburg, 20249, Germany
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Heidelberg, 69120, Germany
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Leipzig, 04103, Germany
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Magdeburg, 39130, Germany
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Mainz, 55101, Germany
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Mönchengladbach, 41061, Germany
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München, 81377, Germany
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Trier, 54290, Germany
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Kfar Saba, 44281, Israel
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Petah Tikva, 49100, Israel
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Rehovot, 76100, Israel
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Tel Aviv, 6423906, Israel
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Bergamo, 24128, Italy
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Bologna, 40138, Italy
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Brescia, 25124, Italy
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Chieti, 66100, Italy
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Genova, 16132, Italy
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Napoli, 80131, Italy
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Orbassano, 10043, Italy
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Parma, 43100, Italy
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San Giovanni Rotondo, 71013, Italy
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Amsterdam, 1105 AZ, Netherlands
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Auckland, 1009, New Zealand
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Christchurch, New Zealand
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Lima, 11, Peru
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Lima, 18, Peru
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Gliwice, 44-101, Poland
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Lublin, 20-081, Poland
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Szczecin, 71-730, Poland
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Wroclaw, 53-413, Poland
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Singapore, 119228, Singapore
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Singapore, 169610, Singapore
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Cape Town, 7506, South Africa
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Pretoria, 0001, South Africa
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Alicante, 03010, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Barcelona, 08041, Spain
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Barcelona, 08907, Spain
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Córdoba, 14004, Spain
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Elche, 03203, Spain
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Madrid, 28040, Spain
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Santander, 39008, Spain
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Valencia, 46009, Spain
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Valencia, 46010, Spain
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Stockholm, 11883, Sweden
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Kueishan, 333, Taiwan
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Taipei, 00112, Taiwan
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Glasgow, G11 6NT, United Kingdom
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Leicester, LE1 5WW, United Kingdom
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London, SW3 6JJ, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Northwood, HA6 2RN, United Kingdom
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Sutton, SM2 5PT, United Kingdom
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Truro, TR1 3LJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2010
First Posted
October 5, 2010
Study Start
July 1, 2005
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
August 13, 2014
Results First Posted
August 13, 2014
Record last verified: 2014-07