Hepatocellular CarcinomaPhase 2NCT00242502
Efficacy and Safety Study of Bevacizumab and Erlotinib to Treat Primary Liver Cancer That Cannot be Removed By Surgery
A Phase 2 study testing Bevacizumab (Avastin) and Erlotinib in people with Hepatocellular Carcinoma and Liver Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The primary objective will be to assess progression-free survival (PFS) measured at 16 weeks following initiation of therapy with the combination of Avastin and erlotinib in patients with unresectable hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cancer
- What is being tested?
- Bevacizumab (Avastin) and Erlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Oct 2011
- Phase
- Phase 2
- 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
- Patients must have histologically confirmed hepatocellular carcinoma not amenable to curative resection.
- Patients must have measurable disease as per the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
- Patients are allowed to have had up to one prior systemic therapy, including chemotherapy or hormonal therapy. Previous treatments that are also allowed that do not count as systemic therapy include: surgical resection, transarterial embolization/chemoembolization (TAE/TACE), radiofrequency ablation (RFA), percutaneous ethanol injection (PEI), provided that the lesion(s) to be evaluated in this study are separate from the previously treated lesions(s). Any prior therapy must have been completed >/= 30 days prior to study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status of </= 2.
- Childs-Pugh status of A or B.
- Organ function: Absolute peripheral granulocyte count of >/= 1500 mm(3), platelet count of >/= 40,000 mm(3), hemoglobin >/= 10 gm/dL. Total bilirubin </= 2.0 gm/dL; serum albumin >/= 2.5 gm/dL; transaminases up to 5 times the upper limit of institutional normal; and prothrombin time prolonged not more than 3 seconds greater than institutional normal, once attempts to correct a prolonged PT have been made. Patients who require full dose anticoagulation, who are otherwise eligible for this trial, are allowed to have an appropriately prolonged International Normalized Ratio (INR).
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- Negative pregnancy test in women with childbearing potential (those who are not surgically sterilized or who are not amenorrheic for >/= 12 months), within one week prior to initiation of treatment.
- Fertile men and women must agree to use adequate contraception prior to study entry and for the duration of study participation.
- Age >/= 18 years. The agents Avastin and erlotinib have not been studied in pediatric patients, thus the doses to be used in this study cannot be assumed to be safe in children.
Who cannot join
- Patients who have had prior vascular endothelial growth factor (VEGF) - or epidermal growth factor receptor (EGFR)-targeted therapy.
- History of prior malignancy other than non-melanoma skin cancer or cervical dysplasia, within five years prior to protocol entry.
- History of ruptured Hepatocellular carcinoma (HCC) lesion, or HCC lesion with large necrotic areas seen on conventional imaging studies, as determined by the Principal Investigator.
- Abnormalities of the cornea based on history (eg dry eye syndrome, Sjogren's syndrome) or congenital abnormality (eg Fuch's dystrophy).
- Gastrointestinal disease resulting in an inability to take oral medication or a requirement for intravenous hyperalimentation.
- Uncontrolled intercurrent illness including but not limited to: ongoing or active infection requiring parenteral therapy; known HIV disease, New York Heart Association Class II or greater heart failure, cardiac arrhythmia not controlled by medication, uncontrolled psychiatric illness, a history of or current evidence of unexplained nephrotic syndrome, history of uncontrolled hypertension (defined as systolic blood pressure >140 and/or diastolic blood pressure > 90) that is refractory to medical management.
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- Patients may not have received any other investigational agents nor have received any systemic chemotherapy </=30 days prior to enrollment.
- History of significant gastrointestinal bleeding requiring procedural intervention (eg variceal banding, TIPS procedure, arterial embolization) within 3 months prior to study enrollment. Patients at risk for varices (based on the following: known history of esophageal or gastric varices; evidence of hepatic cirrhosis and/or portal hypertension including biopsy-proven cirrhosis, hypersplenism, or radiographic findings of varices) will be screened for esophageal varices. If varices are identified that require intervention (banding),patient will not be eligible until varices adequately treated.
- History of myocardial infarction or unstable angina within 6 months.
- History of stroke within 6 months.
- Any prior history of hypertensive crisis or hypertensive encephalopathy.
- Significant or symptomatic vascular disease (e.g., aortic aneurysm, aortic dissection, or peripheral vascular disease).
- Evidence of clinically significant (Common Toxicity Criteria (CTC) Grade 3 or 4) venous or arterial thrombotic disease within previous 6 months.
- Current evidence of bleeding disorder or coagulopathy that is not controlled by conservative medical management.
- Known presence or clinical evidence of central nervous system or brain metastases.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study.
- Minor surgical procedures, fine needle aspirations or core biopsies, excluding placement of a vascular access device, within 7 days prior to Day 0.
- Pregnant (positive pregnancy test) or lactating.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0.
- Serious, non-healing wound, ulcer, or bone fracture.
- Proteinuria at screening as demonstrated by either: Urine protein:creatinine (UPC) ratio >/= 1.0 at screening, or: Urine dipstick for proteinuria >/= 2+ (patients discovered to have >/= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate </= 1g of protein in 24 hours to be eligible).
- Known hypersensitivity to any component of Avastin
- Inability to comply with study and/or follow-up procedures.
- Radiographic evidence of major tumor thrombus in the vena cava.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of the Combination of Bevacizumab and Erlotinib in Patients With Unresectable Hepatocellular Carcinoma
The primary objective will be to assess progression-free survival (PFS) measured at 16 weeks following initiation of therapy with the combination of Avastin and erlotinib in patients with unresectable hepatocellular carcinoma (HCC). Progression-free survival is defined as the time from initiation of therapy until documented disease progression or death.
Secondary objectives include: response rate, median and overall survival, toxicity and tolerability, and to ascertain whether there is any correlation of response with prior treatment status and underlying HCC risk factor(s).
Read the detailed description
Liver cancer growth may be affected by a protein in the body called "vascular epidermal growth factor" (VEGF). A drug that blocks VEGF may be an effective treatment for liver cancer. Avastin is designed to block VEGF. Erlotinib hydrochloride is an investigational drug believed to work on cancer cells by affecting epidermal growth factor receptor (EGFR), a protein that is important to cancer growth.
If the screening evaluations show you are eligible to take part in the study, you may begin treatment. You will receive treatment in 28-day periods called "cycles". Treatment will be given on an outpatient basis. Because this is a research study, the Avastin infusion must be given every time at M. D. Anderson. Because erlotinib hydrochloride is given by mouth, you may take it away from M. D. Anderson.
You will receive Avastin through a needle in a vein on Days 1 and 15 of each cycle. The first dose of Avastin will be given over about 90 minutes. If you do not have a reaction (such as fever/chills), the next dose will be given over about 60 minutes. If again no reaction occurs, each dose after that will be given over about 30 minutes. If you experience a reaction to the Avastin infusion, you may be given acetaminophen (such as Tylenol) by mouth and/or an antihistamine by vein over 30 minutes before each dose to help decrease the risk of further reactions.
You will take erlotinib hydrochloride tablets by mouth every day. It is recommended that erlotinib hydrochloride be taken in the morning with a glass of water. Erlotinib hydrochloride should be taken at least 1 hour before or 2 hours after you have any food, grapefruit juice, vitamins, iron supplements, or other non-prescription medicines.
Before each new cycle of study treatment, you will have urine collected, and blood will be drawn (about 3 tablespoons) for routine blood tests and to check your blood clotting. You will be asked questions about any side effects you may have had and about any medications you are currently taking or have taken since you last saw the study doctor. You will have a complete physical exam, including measurements of vital signs and weight. You will be asked about your ability to perform everyday tasks.
You will also have CT and/or MRI scans of the tumor(s) every 8 weeks. Additional tests may be done during the study if your doctor feels it is necessary for your care. All testing and evaluations must be done at M. D. Anderson.
If you experience severe side effects, treatment may be delayed, stopped, or you may receive smaller doses of the treatment. You may continue to receive study treatment unless the disease gets worse, the side effects are too severe, you decide not to take part any longer, or your doctor decides it is in your best interest to stop treatment. There is no maximum number of cycles that you can receive.
When you stop study treatment, you will be asked to have tests and evaluations done at an end-of-study visit. You will have urine collected, and blood will be drawn (about 3 tablespoons) for routine blood tests and to check your blood clotting. You will be asked questions about any side effects you may have had and about any medications you are currently taking or have taken since you last saw the study doctor. You will have a complete physical exam, including measurements of blood pressure, pulse, temperature, and weight. You will be asked about your ability to perform everyday tasks. You will also have CT and/or MRI scans of the abdomen and pelvis to check on your cancer.
Once you stop receiving study treatment, the study doctor or nurse will continue to check how you are doing, either in the clinic or by telephone if you stop coming to M. D. Anderson, every 3 months for the rest of your life.
This is an investigational study. Erlotinib hydrochloride is approved by the FDA for treatment of lung cancer, but it is not approved for liver cancer, so its use is considered experimental in this study. Avastin is approved by the FDA for treatment of colon and rectal cancer, but it is not approved for the treatment of liver cancer, so its use is considered experimental in this study. Up to 60 participants will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Hepatocellular Carcinoma, Liver Cancer
- Being tested
- Bevacizumab (Avastin), Erlotinib
- Keywords
- Hepatocellular Carcinoma, Liver Cancer, Bevacizumab, Anti-VEGF monoclonal antibody, rhuMAb-VEGF, Erlotinib Hydrochloride, OSI-774, Tarceva, Erlotinib, Avastin
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab (Avastin)Drug
Also called Anti-VEGF monoclonal antibody, rhuMAb-VEGF
10 mg/kg IV every 14 days, repeat cycle every 28 days
ErlotinibDrug
Also called Erlotinib Hydrochloride, OSI-774, Tarceva
150 mg orally every day continuous dosing, repeat cycle every 28 days
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab + Erlotinib | Experimental | Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing. Receives: Drug: Bevacizumab (Avastin); Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) Rate
Progression free survival (PFS) at 16 weeks of treatment with the combination of Avastin and erlotinib where participant said to be failure free at 16 weeks if they are alive, and their disease has not progressed. PFS Rate is number of participants with PFS at 16 weeks out of total participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Measured: Baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionOct 2011
- Study completionOct 2011
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 Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Ahmed Kaseb, M.D., Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242502
- Sponsor's protocol ID
- 2004-0874
- Status last verified
- Mar 2013
- First submitted
- 18 Oct 2005
- Last updated
- 6 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the Combination of Bevacizumab and Erlotinib in Patients With Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00242502
- Acronym / sponsor ID
- 2004-0874
- Conditions
- Hepatocellular Carcinoma, Liver Cancer
- Keywords
- Hepatocellular Carcinoma, Liver Cancer, Bevacizumab, Anti-VEGF monoclonal antibody, rhuMAb-VEGF, Erlotinib Hydrochloride, OSI-774, Tarceva
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Oct 2005
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 20 Oct 2005 (estimated)
- Results
- Posted 6 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective will be to assess progression-free survival (PFS) measured at 16 weeks following initiation of therapy with the combination of Avastin and erlotinib in patients with unresectable hepatocellular carcinoma (HCC). Progression-free survival is defined as the time from initiation of therapy until documented disease progression or death.
Secondary objectives include: response rate, median and overall survival, toxicity and tolerability, and to ascertain whether there is any correlation of response with prior treatment status and underlying HCC risk factor(s).
Detailed description
Liver cancer growth may be affected by a protein in the body called "vascular epidermal growth factor" (VEGF). A drug that blocks VEGF may be an effective treatment for liver cancer. Avastin is designed to block VEGF. Erlotinib hydrochloride is an investigational drug believed to work on cancer cells by affecting epidermal growth factor receptor (EGFR), a protein that is important to cancer growth.
If the screening evaluations show you are eligible to take part in the study, you may begin treatment. You will receive treatment in 28-day periods called "cycles". Treatment will be given on an outpatient basis. Because this is a research study, the Avastin infusion must be given every time at M. D. Anderson. Because erlotinib hydrochloride is given by mouth, you may take it away from M. D. Anderson.
You will receive Avastin through a needle in a vein on Days 1 and 15 of each cycle. The first dose of Avastin will be given over about 90 minutes. If you do not have a reaction (such as fever/chills), the next dose will be given over about 60 minutes. If again no reaction occurs, each dose after that will be given over about 30 minutes. If you experience a reaction to the Avastin infusion, you may be given acetaminophen (such as Tylenol) by mouth and/or an antihistamine by vein over 30 minutes before each dose to help decrease the risk of further reactions.
You will take erlotinib hydrochloride tablets by mouth every day. It is recommended that erlotinib hydrochloride be taken in the morning with a glass of water. Erlotinib hydrochloride should be taken at least 1 hour before or 2 hours after you have any food, grapefruit juice, vitamins, iron supplements, or other non-prescription medicines.
Before each new cycle of study treatment, you will have urine collected, and blood will be drawn (about 3 tablespoons) for routine blood tests and to check your blood clotting. You will be asked questions about any side effects you may have had and about any medications you are currently taking or have taken since you last saw the study doctor. You will have a complete physical exam, including measurements of vital signs and weight. You will be asked about your ability to perform everyday tasks.
You will also have CT and/or MRI scans of the tumor(s) every 8 weeks. Additional tests may be done during the study if your doctor feels it is necessary for your care. All testing and evaluations must be done at M. D. Anderson.
If you experience severe side effects, treatment may be delayed, stopped, or you may receive smaller doses of the treatment. You may continue to receive study treatment unless the disease gets worse, the side effects are too severe, you decide not to take part any longer, or your doctor decides it is in your best interest to stop treatment. There is no maximum number of cycles that you can receive.
When you stop study treatment, you will be asked to have tests and evaluations done at an end-of-study visit. You will have urine collected, and blood will be drawn (about 3 tablespoons) for routine blood tests and to check your blood clotting. You will be asked questions about any side effects you may have had and about any medications you are currently taking or have taken since you last saw the study doctor. You will have a complete physical exam, including measurements of blood pressure, pulse, temperature, and weight. You will be asked about your ability to perform everyday tasks. You will also have CT and/or MRI scans of the abdomen and pelvis to check on your cancer.
Once you stop receiving study treatment, the study doctor or nurse will continue to check how you are doing, either in the clinic or by telephone if you stop coming to M. D. Anderson, every 3 months for the rest of your life.
This is an investigational study. Erlotinib hydrochloride is approved by the FDA for treatment of lung cancer, but it is not approved for liver cancer, so its use is considered experimental in this study. Avastin is approved by the FDA for treatment of colon and rectal cancer, but it is not approved for the treatment of liver cancer, so its use is considered experimental in this study. Up to 60 participants will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab + Erlotinib | Experimental | Drug: Bevacizumab (Avastin), Drug: ErlotinibBevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have histologically confirmed hepatocellular carcinoma not amenable to curative resection.
- Patients must have measurable disease as per the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
- Patients are allowed to have had up to one prior systemic therapy, including chemotherapy or hormonal therapy. Previous treatments that are also allowed that do not count as systemic therapy include: surgical resection, transarterial embolization/chemoembolization (TAE/TACE), radiofrequency ablation (RFA), percutaneous ethanol injection (PEI), provided that the lesion(s) to be evaluated in this study are separate from the previously treated lesions(s). Any prior therapy must have been completed >/= 30 days prior to study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status of </= 2.
- Childs-Pugh status of A or B.
Key exclusion criteria (24 listed)
- Patients who have had prior vascular endothelial growth factor (VEGF) - or epidermal growth factor receptor (EGFR)-targeted therapy.
- History of prior malignancy other than non-melanoma skin cancer or cervical dysplasia, within five years prior to protocol entry.
- History of ruptured Hepatocellular carcinoma (HCC) lesion, or HCC lesion with large necrotic areas seen on conventional imaging studies, as determined by the Principal Investigator.
- Abnormalities of the cornea based on history (eg dry eye syndrome, Sjogren's syndrome) or congenital abnormality (eg Fuch's dystrophy).
- Gastrointestinal disease resulting in an inability to take oral medication or a requirement for intravenous hyperalimentation.
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)Also: Anti-VEGF monoclonal antibody, rhuMAb-VEGF10 mg/kg IV every 14 days, repeat cycle every 28 days | Drug | Bevacizumab + Erlotinib |
| ErlotinibAlso: Erlotinib Hydrochloride, OSI-774, Tarceva150 mg orally every day continuous dosing, repeat cycle every 28 days | Drug | Bevacizumab + Erlotinib |
Primary outcome
Progression-free Survival (PFS) Rate
Time frame: Baseline to 16 weeks
Progression free survival (PFS) at 16 weeks of treatment with the combination of Avastin and erlotinib where participant said to be failure free at 16 weeks if they are alive, and their disease has not progressed. PFS Rate is number of participants with PFS at 16 weeks out of total participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The University of Texas (UT) MD Anderson Cancer Center official websiteLink provided by the sponsor.
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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.
Ahmed Kaseb, M.D. principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab (Avastin) and Erlotinib in people with Hepatocellular Carcinoma and Liver Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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 9 inclusion and 24 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 6 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 6 May 2013). 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?
Progression-free Survival (PFS) Rate (time frame: Baseline to 16 weeks). 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 6 May 2013.