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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/NCT02013830
Registration number
NCT02013830
Ethics application status
Date submitted
3/12/2013
Date registered
17/12/2013
Date last updated
6/06/2014
Titles & IDs
Public title
A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) in Patients With Advanced or Metastatic Liver Cancer
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Scientific title
A Single-arm, Open-label Study of Avastin Plus Xeloda on Objective Treatment Response in Patients With Advanced or Metastatic Liver Cancer Who Have Had no Previous Cytotoxic Chemotherapy
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Secondary ID [1]
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ML18469
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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:
Liver Cancer
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Condition category
Condition code
Cancer
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Liver
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - bevacizumab [Avastin]
Treatment: Drugs - capecitabine [Xeloda]
Experimental: Avastin + Xeloda -
Treatment: Drugs: bevacizumab [Avastin]
7.5mg/kg iv on day 1 of each 3 week cycle.
Treatment: Drugs: capecitabine [Xeloda]
1600mg/m2/day po in 2 divided doses, on days 1 to 14 of each 3 week cycle.
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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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Percentage of Participants With Objective Response (OR)
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Assessment method [1]
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Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as greater than or equal to (=) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions.
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Timepoint [1]
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Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
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Secondary outcome [1]
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Percentage of Participants With Disease Control
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Assessment method [1]
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The percentage of participants with disease control was based on assessment of confirmed CR, PR, or stable disease (SD) according to RECIST criteria. Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as = 30 % decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions. SD was defined as not qualifying for PR or progressive disease.
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Timepoint [1]
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Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
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Secondary outcome [2]
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Time to Disease Progression - Percentage of Participants With an Event
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Assessment method [2]
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Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.
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Timepoint [2]
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Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
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Secondary outcome [3]
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Time to Disease Progression
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Assessment method [3]
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Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of their tumor assessment.
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Timepoint [3]
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Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
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Secondary outcome [4]
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Time to Disease Progression - Percentage of Participants Progression-free at 12 Months
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Assessment method [4]
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Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.
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Timepoint [4]
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Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
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Secondary outcome [5]
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Overall Survival - Percentage of Participants With an Event
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Assessment method [5]
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Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive.
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Timepoint [5]
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Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
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Secondary outcome [6]
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Overall Survival
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Assessment method [6]
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Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive. Median Overall Survival was estimated using the Kaplan-Meier method.
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Timepoint [6]
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Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
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Secondary outcome [7]
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Overall Survival - Percentage of Participants Event Free at 12 Months
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Assessment method [7]
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Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive.
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Timepoint [7]
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Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
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Eligibility
Key inclusion criteria
- adult patients >=18 years of age;
- advanced or metastatic liver cancer;
- >=1 measurable lesion.
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Minimum age
18
Years
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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
- current radiotherapy, chemotherapy, or other experimental therapies;
- prior cytotoxic chemotherapy;
- major surgery, open biopsy, or traumatic injury within 28 days of study entry;
- history of a malignancy during the last 5 years, other than cutaneous basal cell
cancer or in situ cervical cancer.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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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
1/05/2005
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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
1/03/2008
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Sample size
Target
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Accrual to date
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Final
45
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Melbourne
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Recruitment postcode(s) [1]
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3181 - Melbourne
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Recruitment outside Australia
Country [1]
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Hong Kong
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State/province [1]
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Hong Kong
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Country [2]
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Singapore
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State/province [2]
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Singapore
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Country [3]
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Taiwan
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State/province [3]
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Kueishan
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Country [4]
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Taiwan
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State/province [4]
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the efficacy and safety of oral Xeloda (capecitabine) plus
intravenous Avastin (bevacizumab) in patients with advanced or metastatic liver cancer. The
anticipated time on study treatment is 3-12 months.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02013830
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-La Roche
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02013830
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