Gemcitabine and Capecitabine With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
NCT ID: NCT00425360
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1110 participants
INTERVENTIONAL
2006-09-30
2013-03-31
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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sargramostim
telomerase peptide vaccine GV1001
capecitabine
gemcitabine hydrochloride
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Royal Liverpool University Hospital
OTHER_GOV
Principal Investigators
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Gary W. Middleton
Role: STUDY_CHAIR
St. Luke's Cancer Centre at Royal Surrey County Hospital
Locations
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North Devon District Hospital
Barnstaple, England, United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom
Pilgrim Hospital
Boston, England, United Kingdom
Royal Bournemouth Hospital
Bournemouth, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Darent Valley Hospital
Dartford Kent, England, United Kingdom
Dorset County Hospital
Dorchester, England, United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, United Kingdom
Ipswich Hospital
Ipswich, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Royal Liverpool University Hospital
Liverpool, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
Cancer Research UK Clinical Groups at Guy's King's & St. Thomas' Hospitals
London, England, United Kingdom
St. George's Hospital
London, England, United Kingdom
Royal Marsden - London
London, England, United Kingdom
Christie Hospital
Manchester, England, United Kingdom
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom
James Cook University Hospital
Middlesbrough, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
James Paget Hospital
Norfolk, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Norfolk and Norwich University Hospital
Norwich, England, United Kingdom
Nottingham City Hospital
Nottingham, England, United Kingdom
Churchill Hospital
Oxford, England, United Kingdom
Peterborough Hospitals Trust
Peterborough, England, United Kingdom
Dorset Cancer Centre
Poole Dorset, England, United Kingdom
Portsmouth Oncology Centre at Saint Mary's Hospital
Portsmouth Hants, England, United Kingdom
Conquest Hospital
Saint Leonards-on-Sea, England, United Kingdom
Salisbury District Hospital
Salisbury, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom
Wexham Park Hospital
Slough, Berkshire, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Torbay Hospital
Torquay Devon, England, United Kingdom
Royal Cornwall Hospital
Truro, Cornwall, England, United Kingdom
Worthing Hospital
Worthing, England, United Kingdom
Yeovil District Hospital
Yeovil, England, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, United Kingdom
Wrexham Maelor Hospital
Wrexham, Wales, United Kingdom
Countries
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Other Identifiers
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CRUK-TELOVAC-V4
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2006-000461-10
Identifier Type: -
Identifier Source: secondary_id
EU-20683
Identifier Type: -
Identifier Source: secondary_id
ISRTCN43482138
Identifier Type: -
Identifier Source: secondary_id
CDR0000528021
Identifier Type: -
Identifier Source: org_study_id