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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: bevacizumab [Avastin]

• Study Type: Interventional
• Enrollment (Actual): 607
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, 5011
  • Camperdown, Australia, 2050
  • Footscray, Australia, 3011
  • Heidelberg, Australia, 3084
  • Kurralta Park, Australia, 5037
  • Melbourne, Australia, 3002
  • Melbourne, Australia, 3128
  • St. Leonards, Australia, 2065
  • Sydney, Australia, 2031
  • Sydney, Australia, 2217
• Austria
  • Graz, Austria, 8036
  • Innsbruck, Austria, 6020
  • Salzburg, Austria, 5020
  • Wien, Austria, 1090
• Belgium
  • Antwerpen, Belgium, 2020
  • Bruxelles, Belgium, 1070
  • Bruxelles, Belgium, 1200
  • Leuven, Belgium, 3000
  • Wilrijk, Belgium, 2610
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
    • Toronto, Ontario, Canada, M5G 2M9
  • Quebec
    • Montreal, Quebec, Canada, H2W 1S6
    • Quebec City, Quebec, Canada, G1R 2J6
• China
  • Beijing, China, 100071
  • Beijing, China, 100036
  • Shanghai, China, 200433
• Czech Republic
  • Brno, Czech Republic, 656 53
  • Hradec Kralove, Czech Republic, 500 05
• Finland
  • Helsinki, Finland, 00029
• France
  • Besancon, France, 25030
  • Bordeaux, France, 33000
  • Boulogne-billancourt, France, 92104
  • Clichy, France, 92118
  • Limoges, France, 87042
  • Marseille, France, 13273
  • Paris, France, 75674
  • Paris, France, 75679
  • Rouen, France, 76031
  • Saint Herblain, France, 44805
  • Strasbourg, France, 67091
• Germany
  • Berlin, Germany, 13353
  • Bochum, Germany, 44892
  • Bonn, Germany, 53127
  • Halle, Germany, 06120
  • Hamburg, Germany, 20249
  • Heidelberg, Germany, 69120
  • Leipzig, Germany, 04103
  • Magdeburg, Germany, 39130
  • Mainz, Germany, 55101
  • Muenchen, Germany, 81377
  • Mönchengladbach, Germany, 41061
  • Trier, Germany, 54290
• Israel
  • Kfar Saba, Israel, 44281
  • Petach Tikva, Israel, 49100
  • Rehovot, Israel, 76100
  • Tel Aviv, Israel, 6423906
• Italy
  • Bergamo, Italy, 24128
  • Bologna, Italy, 40138
  • Brescia, Italy, 25124
  • Chieti, Italy, 66100
  • Genova, Italy, 16132
  • Napoli, Italy, 80131
  • Orbassano, Italy, 10043
  • Parma, Italy, 43100
  • San Giovanni Rotondo, Italy, 71013
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
• New Zealand
  • Auckland, New Zealand, 1009
  • Christchurch, New Zealand
• Peru
  • Lima, Peru, 11
  • Lima, Peru, 18
• Poland
  • Gliwice, Poland, 44-101
  • Lublin, Poland, 20-081
  • Szczecin, Poland, 71-730
  • Wroclaw, Poland, 53-413
• Singapore
  • Singapore, Singapore, 119228
  • Singapore, Singapore, 169610
• South Africa
  • Cape Town, South Africa, 7506
  • Pretoria, South Africa, 0001
• Spain
  • Alicante, Spain, 03010
  • Barcelona, Spain, 08036
  • Barcelona, Spain, 08035
  • Barcelona, Spain, 08907
  • Barcelona, Spain, 08041
  • Cordoba, Spain, 14004
  • Elche, Spain, 03203
  • Madrid, Spain, 28040
  • Santander, Spain, 39008
  • Valencia, Spain, 46010
  • Valencia, Spain, 46009
• Sweden
  • Stockholm, Sweden, 11883
• Taiwan
  • Kueishan, Taiwan, 333
  • Taipei, Taiwan, 00112
• United Kingdom
  • Glasgow, United Kingdom, G11 6NT
  • Leicester, United Kingdom, LE1 5WW
  • London, United Kingdom, SW3 6JJ
  • Manchester, United Kingdom, M20 4BX
  • Northwood, United Kingdom, HA6 2RN
  • Sutton, United Kingdom, SM2 5PT
  • Truro, United Kingdom, TR1 3LJ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: bevacizumab [Avastin]; Intervenous repeating dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	PFS was defined as the time between the date of randomization and the date of documented progressive disease (PD) defined according to modified Response Evaluation Criteria in Solid Tumors (RECIST) evaluation, or date of death due to any cause. PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum (LD) recorded since the treatment started. Participants without an event were censored at the date of last follow up for progression, or date of last available tumor assessment if no further follow up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization.	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	PFS was defined as the time between the date of randomization and the date of documented PD (per RECIST), or date of death due to any cause. Data for participants without an event were censored at the date of last follow up for progression, or date of last available tumor assessment if no further follow up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization. Median PFS was estimated using the Kaplan-Meier method.	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	Percentage of participants with CR, PR, or SD according to modified RECIST evaluation at the first postbaseline tumor assessment. CR equaled (=) complete disappearance of all target lesions and non-target disease, with normalization of tumor marker level. PR is greater than or equal to (≥) a 30% decrease of the sum of the LD of all target lesions as referenced to the baseline sum LD of all target lesions. Persistence of one or more non-target lesions(s) and/or maintenance of tumor marker level above normal limits. SD=neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for PD with persistence of one or more non-target lesions(s) and/or maintenance of tumor marker level above normal limits.	Baseline and Week 8
Bevacizumab Concentration in the Presence of Gemcitabine and Erlotinib	Blood samples were collected from a subgroup of participants, in selected centers for the determination of bevacizumab serum concentration before the first bevacizumab/placebo exposure (Week 1) and at Weeks 3, 5, 7, and 9. Each time blood samples were collected just (preferably within 1 hour) before the start of the study treatment.	Weeks 1, 3, 5, 7, and 9

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: October 4, 2010
• First Submitted That Met QC Criteria: October 4, 2010
• First Posted (Estimate): October 5, 2010

Study Record Updates

• Last Update Posted (Estimate): August 13, 2014
• Last Update Submitted That Met QC Criteria: July 23, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: BO17706