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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01214720
Registration number
NCT01214720
Ethics application status
Date submitted
4/10/2010
Date registered
5/10/2010
Date last updated
13/08/2014
Titles & IDs
Public title
A Study of Avastin (Bevacizumab) Added to a Chemotherapeutic Regimen in Patients With Metastatic Pancreatic Cancer
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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
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Secondary ID [1]
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BO17706
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer
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Condition category
Condition code
Cancer
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Pancreatic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - bevacizumab [Avastin]
Experimental: 1 -
Treatment: Drugs: bevacizumab [Avastin]
Intervenous repeating dose
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Duration of Overall Survival - Percentage of Participants With an Event
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Assessment method [1]
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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.
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Timepoint [1]
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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
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Primary outcome [2]
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Duration of Overall Survival - Time to Event
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Assessment method [2]
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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.
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Timepoint [2]
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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
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Secondary outcome [1]
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Clinical Benefit Response (CBR)
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Assessment method [1]
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Timepoint [1]
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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
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Secondary outcome [2]
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Progression-Free Survival (PFS) - Percentage of Participants With an Event
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Assessment method [2]
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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.
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Timepoint [2]
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Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression
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Secondary outcome [3]
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Progression-Free Survival (PFS) - Time to Event
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Assessment method [3]
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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.
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Timepoint [3]
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Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression
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Secondary outcome [4]
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Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at First Postbaseline Tumor Assessment
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline and Week 8
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Secondary outcome [5]
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Bevacizumab Concentration in the Presence of Gemcitabine and Erlotinib
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Assessment method [5]
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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.
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Timepoint [5]
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Weeks 1, 3, 5, 7, and 9
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Eligibility
Key inclusion criteria
- adult patients, >=18 years of age;
- metastatic pancreatic cancer (adenocarcinoma);
- good liver, kidney, and bone marrow function.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2008
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Sample size
Target
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Accrual to date
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Final
607
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Recruitment in Australia
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- Adelaide
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- Camperdown
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5011 - Adelaide
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2050 - Camperdown
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3011 - Footscray
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3084 - Heidelberg
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5037 - Kurralta Park
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3002 - Melbourne
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3128 - Melbourne
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2065 - St. Leonards
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2031 - Sydney
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2217 - Sydney
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Austria
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Graz
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01214720
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Trial related presentations / publications
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Contacts
Principal investigator
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Hoffmann-La Roche
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01214720
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