Pancreatic CancerPhase 3NCT01214720
A Study of Avastin (Bevacizumab) Added to a Chemotherapeutic Regimen in Patients With Metastatic Pancreatic Cancer
A Phase 3 study testing bevacizumab [Avastin] in people with Pancreatic Cancer, run by Hoffmann-La Roche at 101 sites in 21 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- bevacizumab [Avastin]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 607 participants
- Where
- 101 sitesin 21 countries
- Study dates
- Jul 2005to Oct 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients, >=18 years of age;
- metastatic pancreatic cancer (adenocarcinoma);
- good liver, kidney, and bone marrow function.
Who cannot join
- 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.
Trial locations and contacts
101 sites in 21 countries.
101 sites in 21 countries
Germany12 sites
Study site
Berlin, 13353
Study site
Bochum, 44892
Study site
Bonn, 53127
Study site
Halle, 06120
Study site
Hamburg, 20249
Study site
Heidelberg, 69120
Study site
Leipzig, 04103
Study site
Magdeburg, 39130
Study site
Mainz, 55101
Study site
Mönchengladbach, 41061
Study site
München, 81377
Study site
Trier, 54290
France11 sites
Study site
Besançon, 25030
Study site
Bordeaux, 33000
Study site
Boulogne-Billancourt, 92104
Study site
Clichy, 92118
Study site
Limoges, 87042
Study site
Marseille, 13273
Study site
Paris, 75674
Study site
Paris, 75679
Study site
Rouen, 76031
Study site
Saint-Herblain, 44805
Study site
Strasbourg, 67091
Spain11 sites
Study site
Alicante, 03010
Study site
Barcelona, 08035
Study site
Barcelona, 08036
Study site
Barcelona, 08041
Study site
Barcelona, 08907
Study site
Córdoba, 14004
Study site
Elche, 03203
Study site
Madrid, 28040
Study site
Santander, 39008
Study site
Valencia, 46009
Study site
Valencia, 46010
Australia10 sites
Study site
Adelaide, 5011
Study site
Camperdown, 2050
Study site
Footscray, 3011
Study site
Heidelberg, 3084
Study site
Kurralta Park, 5037
Study site
Melbourne, 3002
Study site
Melbourne, 3128
Study site
St Leonards, 2065
Study site
Sydney, 2031
Study site
Sydney, 2217
Italy9 sites
Study site
Bergamo, 24128
Study site
Bologna, 40138
Study site
Brescia, 25124
Study site
Chieti, 66100
Study site
Genova, 16132
Study site
Naples, 80131
Study site
Orbassano, 10043
Study site
Parma, 43100
Study site
San Giovanni Rotondo, 71013
United Kingdom7 sites
Study site
Glasgow, G11 6NT
Study site
Leicester, LE1 5WW
Study site
London, SW3 6JJ
Study site
Manchester, M20 4BX
Study site
Northwood, HA6 2RN
Study site
Sutton, SM2 5PT
Study site
Truro, TR1 3LJ
Canada6 sites
Study site
Edmonton, Alberta, T6G 1Z2
Study site
Montreal, Quebec, H2W 1S6
Study site
Ottawa, Ontario, K1H 8L6
Study site
Québec, Quebec, G1R 2J6
Study site
Toronto, Ontario, M5G 2M9
Study site
Vancouver, British Columbia, V5Z 4E6
Belgium5 sites
Study site
Antwerp, 2020
Study site
Brussels, 1070
Study site
Brussels, 1200
Study site
Leuven, 3000
Study site
Wilrijk, 2610
Austria4 sites
Study site
Graz, 8036
Study site
Innsbruck, 6020
Study site
Salzburg, 5020
Study site
Vienna, 1090
Israel4 sites
Study site
Kfar Saba, 44281
Study site
Petah Tikva, 49100
Study site
Rehovot, 76100
Study site
Tel Aviv, 6423906
Poland4 sites
Study site
Gliwice, 44-101
Study site
Lublin, 20-081
Study site
Szczecin, 71-730
Study site
Wroclaw, 53-413
China3 sites
Study site
Beijing, 100036
Study site
Beijing, 100071
Study site
Shanghai, 200433
About this study
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
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.
- Conditions
- Pancreatic Cancer
- Being tested
- bevacizumab [Avastin]
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumab [Avastin]Drug
Intervenous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: bevacizumab [Avastin] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 1, 3, 5, 7, and 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startJul 2005
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 607 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214720
- Sponsor's protocol ID
- BO17706
- Status last verified
- Jul 2014
- First submitted
- 4 Oct 2010
- Last updated
- 13 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01214720
- Acronym / sponsor ID
- BO17706
- Conditions
- Pancreatic Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 607 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 5 Oct 2010 (estimated)
- Results
- Posted 13 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: bevacizumab [Avastin] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients, >=18 years of age;
- metastatic pancreatic cancer (adenocarcinoma);
- good liver, kidney, and bone marrow function.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bevacizumab [Avastin]Intervenous repeating dose | Drug | 1 |
Primary outcome
Duration of Overall Survival - Percentage of Participants With an Event
Time frame: 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 (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.
Duration of Overall Survival - Time to Event
Time frame: 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 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.
5 secondary outcomes
Clinical Benefit Response (CBR)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and Week 8
Bevacizumab Concentration in the Presence of Gemcitabine and Erlotinib
Time frame: Weeks 1, 3, 5, 7, and 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
101 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bevacizumab [Avastin] in people with Pancreatic Cancer, run by Hoffmann-La Roche at 101 sites in 21 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 101 sites in Germany, France, Spain, Australia, Italy and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Overall Survival - Percentage of Participants With an Event (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014.