Pancreatic CancerPhase 3NCT00425360
Gemcitabine and Capecitabine With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
A Phase 3 study testing sargramostim, telomerase peptide vaccine GV1001 and capecitabine in people with Pancreatic Cancer, run by Royal Liverpool University Hospital at 45 sites in United Kingdom.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. 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?
- sargramostim, telomerase peptide vaccine GV1001 and capecitabine
- Type of treatment
- Vaccines
- How many people
- 1,110 participants
- Where
- 45 sitesUnited Kingdom
- Study dates
- Sep 2006to Mar 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
- Locally advanced or metastatic disease precluding curative surgical resection
- Unidimensionally measurable disease by CT scan
- No intracerebral metastases or meningeal carcinomatosis
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 3 months
- WBC > 3,000/mm³
- Absolute neutrophil count > 1,500/mm³
- Platelet count > 100,000/mm³
- Bilirubin < 2.0 mg/dL
- Creatinine clearance > 50 mL/min
- No medical or psychiatric condition that would preclude giving informed consent
- No clinically significant serious disease or organ system disease not currently controlled on present therapy
- No uncontrolled angina pectoris
- Not pregnant or nursing
- Fertile patients must use a condom and ≥ 1 other form of contraception during and for 1 year after completion of study treatment
- No other malignancies or invasive cancers within the past 5 years except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
- No known malabsorption syndrome
- No known hypersensitivity to any of the investigational agents
- No dihydropyrimidine dehydrogenase deficiency
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy
- No radiotherapy within the past 4 weeks
- No concurrent medications that could affect immunocompetence (e.g., chronic treatment with long-term steroids or other immunosuppressants for unrelated condition)
- Concurrent short-term steroids for palliation of cancer-related symptoms allowed
- No other concurrent investigational drugs or cytotoxic agents
- No other concurrent immunotherapy (e.g., immunosuppressants or chronic use of systemic corticosteroids) or chemotherapy for another tumor in patients receiving telomerase peptide vaccine GV1001
- Concurrent low-dose corticosteroids may be allowed
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United Kingdom45 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
North Devon District Hospital
Barnstaple, England, EX31 4JB
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, RG24 9NA
Pilgrim Hospital
Boston, England, PE21 9QT
Royal Bournemouth Hospital
Bournemouth, England, BH7 7DW
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, BN2 5BE
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED
Addenbrooke's Hospital
Cambridge, England, CB2 0QQ
Darent Valley Hospital
Dartford Kent, England, DA2 8DA
Dorset County Hospital
Dorchester, England, DT1 2JY
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G11 6NT
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, GU2 7XX
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, HD3 3EA
Ipswich Hospital
Ipswich, England, IP4 5PD
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Leicester Royal Infirmary
Leicester, England, LE1 5WW
Royal Liverpool University Hospital
Liverpool, England, L7 8XP
Saint Bartholomew's Hospital
London, England, EC1A 7BE
Cancer Research UK Clinical Groups at Guy's King's & St. Thomas' Hospitals
London, England, SE5 9NU
St. George's Hospital
London, England, SW17 0QT
Royal Marsden - London
London, England, SW3 6JJ
Christie Hospital
Manchester, England, M20 4BX
Clatterbridge Centre for Oncology
Merseyside, England, CH63 4JY
James Cook University Hospital
Middlesbrough, England, TS4 3BW
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
James Paget Hospital
Norfolk, England, NR31 6LA
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, HA6 2RN
Norfolk and Norwich University Hospital
Norwich, England, NR4 7UY
Nottingham City Hospital
Nottingham, England, NG5 1PB
Churchill Hospital
Oxford, England, OX3 7LJ
Peterborough Hospitals Trust
Peterborough, England, PE3 6DA
Dorset Cancer Centre
Poole Dorset, England, BH15 2JB
Portsmouth Oncology Centre at Saint Mary's Hospital
Portsmouth Hants, England, PO3 6AD
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, LL 18 5UJ
Conquest Hospital
Saint Leonards-on-Sea, England, TN37 7RD
Salisbury District Hospital
Salisbury, England, SP2 8BJ
Cancer Research Centre at Weston Park Hospital
Sheffield, England, S10 2SJ
Wexham Park Hospital
Slough, Berkshire, England, SL2 4HL
Royal Marsden - Surrey
Sutton, England, SM2 5PT
Torbay Hospital
Torquay Devon, England, TQ2 7AA
Royal Cornwall Hospital
Truro, Cornwall, England, TR1 3LJ
Worthing Hospital
Worthing, England, BN11 2DH
Wrexham Maelor Hospital
Wrexham, Wales, LL13 7TD
Yeovil District Hospital
Yeovil, England, BA21 4AT
About this study
Official title: A Prospective, Phase III, Controlled, Multicentre, Randomised Clinical Trial Comparing Combination Gemcitabine and Capecitabine Therapy With Concurrent and Sequential Chemoimmunotherapy Using a Telomerase Vaccine in Locally Advanced and Metastatic Pancreatic Cancer [TELOVAC]
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving more than one drug (combination chemotherapy) together with vaccine therapy may kill more tumor cells. It is not yet known whether chemotherapy is more effective with or without vaccine therapy in treating pancreatic cancer.
PURPOSE: This randomized phase III trial is studying gemcitabine, capecitabine, and vaccine therapy to see how well they work compared with gemcitabine and capecitabine alone in treating patients with locally advanced or metastatic pancreatic cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the efficacy of telomerase peptide vaccine GV1001 when administered concurrently or sequentially with gemcitabine hydrochloride and capecitabine, in terms of survival, in patients with locally advanced or metastatic pancreatic cancer.
Secondary
- Determine the safety of this regimen in these patients.
- Assess the immunogenicity of this regimen in these patients.
- Determine the time to progression in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the clinical benefit response in patients treated with this regimen.
- Determine the objective response rate in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the survival and response by delayed-type hypersensitivity in patients treated with this regimen.
OUTLINE: This is a prospective, controlled, randomized, open-label, multicenter study. Patients are stratified according to stage of disease (locally advanced vs metastatic) and ECOG performance status (0 vs 1 vs 2). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive gemcitabine hydrochloride and capecitabine as in arm I. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sargramostim (GM-CSF) intradermally (ID) and telomerase peptide vaccine GV1001 ID on days 1, 3, and 5 in week 9, once a week in weeks 10-12 and 14, and then once a month in the absence of disease progression or unacceptable toxicity. Patients who develop disease progression while on vaccine therapy, discontinue vaccine therapy and then restart treatment with gemcitabine hydrochloride and capecitabine. Patients receive gemcitabine hydrochloride and capecitabine as above and continue treatment in the absence of further disease progression or unacceptable toxicity.
- Arm III: Patients receive gemcitabine hydrochloride and capecitabine as in arm I. Patients also receive GM-CSF ID and telomerase peptide vaccine GV1001 ID on days 1, 3, and 5 in week 1, once weekly in weeks 2, 3, 4 and 6, and then once a month in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and at 8 weeks and then every 12 weeks during study treatment.
After completion of study treatment, patients are followed every 3 months.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 1,110 patients will be accrued for this study.
- Conditions
- Pancreatic Cancer
- Being tested
- sargramostim, telomerase peptide vaccine GV1001, capecitabine, gemcitabine hydrochloride
- Keywords
- stage III pancreatic cancer, stage IV pancreatic cancer, duct cell adenocarcinoma of the pancreas, recurrent pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sargramostimBiological
telomerase peptide vaccine GV1001Biological
capecitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at 1 year
Secondary outcomes (6)
Time to progression
Quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life (QLQ) C30 questionnaire and the European Study group for Pancreatic Cancer-QLQ questionnaire
Clinical benefit response
Objective response rate as assessed by RECIST criteria
Toxicity as assessed by NCI CTCAE version 3
Survival and response as assessed by delayed-type hypersensitivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2007 (estimated)
- Study startSep 2006
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 1,110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Liverpool University Hospital
- Sponsor type
- Other government
- Investigators
- Gary W. Middleton, Study chair, St. Luke's Cancer Centre at Royal Surrey County Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425360
- Sponsor's protocol ID
- CDR0000528021
- Other IDs
- CRUK-TELOVAC-V4, EUDRACT-2006-000461-10, EU-20683, ISRTCN43482138
- Status last verified
- May 2009
- First submitted
- 19 Jan 2007
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Phase III, Controlled, Multicentre, Randomised Clinical Trial Comparing Combination Gemcitabine and Capecitabine Therapy With Concurrent and Sequential Chemoimmunotherapy Using a Telomerase Vaccine in Locally Advanced and Metastatic Pancreatic Cancer [TELOVAC]
- ClinicalTrials.gov ID
- NCT00425360
- Acronym / sponsor ID
- CDR0000528021
- Conditions
- Pancreatic Cancer
- Keywords
- stage III pancreatic cancer, stage IV pancreatic cancer, duct cell adenocarcinoma of the pancreas, recurrent pancreatic cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,110 participants (estimated)
- Lead sponsor
- Royal Liverpool University HospitalOther government
- Study start
- Sep 2006
- Study completion
- Mar 2013 (actual)
- First posted
- 23 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving more than one drug (combination chemotherapy) together with vaccine therapy may kill more tumor cells. It is not yet known whether chemotherapy is more effective with or without vaccine therapy in treating pancreatic cancer.
PURPOSE: This randomized phase III trial is studying gemcitabine, capecitabine, and vaccine therapy to see how well they work compared with gemcitabine and capecitabine alone in treating patients with locally advanced or metastatic pancreatic cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the efficacy of telomerase peptide vaccine GV1001 when administered concurrently or sequentially with gemcitabine hydrochloride and capecitabine, in terms of survival, in patients with locally advanced or metastatic pancreatic cancer.
Secondary
- Determine the safety of this regimen in these patients.
- Assess the immunogenicity of this regimen in these patients.
- Determine the time to progression in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the clinical benefit response in patients treated with this regimen.
- Determine the objective response rate in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the survival and response by delayed-type hypersensitivity in patients treated with this regimen.
OUTLINE: This is a prospective, controlled, randomized, open-label, multicenter study. Patients are stratified according to stage of disease (locally advanced vs metastatic) and ECOG performance status (0 vs 1 vs 2). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive gemcitabine hydrochloride and capecitabine as in arm I. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sargramostim (GM-CSF) intradermally (ID) and telomerase peptide vaccine GV1001 ID on days 1, 3, and 5 in week 9, once a week in weeks 10-12 and 14, and then once a month in the absence of disease progression or unacceptable toxicity. Patients who develop disease progression while on vaccine therapy, discontinue vaccine therapy and then restart treatment with gemcitabine hydrochloride and capecitabine. Patients receive gemcitabine hydrochloride and capecitabine as above and continue treatment in the absence of further disease progression or unacceptable toxicity.
- Arm III: Patients receive gemcitabine hydrochloride and capecitabine as in arm I. Patients also receive GM-CSF ID and telomerase peptide vaccine GV1001 ID on days 1, 3, and 5 in week 1, once weekly in weeks 2, 3, 4 and 6, and then once a month in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and at 8 weeks and then every 12 weeks during study treatment.
After completion of study treatment, patients are followed every 3 months.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 1,110 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| sargramostim | Biological | – |
| telomerase peptide vaccine GV1001 | Biological | – |
| capecitabine | Drug | – |
| gemcitabine hydrochloride | Drug | – |
Primary outcome
Survival at 1 year
6 secondary outcomes
Time to progression
Quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life (QLQ) C30 questionnaire and the European Study group for Pancreatic Cancer-QLQ questionnaire
Clinical benefit response
Objective response rate as assessed by RECIST criteria
Toxicity as assessed by NCI CTCAE version 3
Survival and response as assessed by delayed-type hypersensitivity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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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.
Gary W. Middleton study chair
St. Luke's Cancer Centre at Royal Surrey County Hospital
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sargramostim, telomerase peptide vaccine GV1001 and capecitabine in people with Pancreatic Cancer, run by Royal Liverpool University Hospital at 45 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Survival at 1 year. 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 26 Aug 2013.