Gemcitabine and Capecitabine With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT00425360
- Lead Sponsor
- Royal Liverpool University Hospital
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1110
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival at 1 year
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (45)
Pilgrim Hospital
🇬🇧Boston, England, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
Dorset County Hospital
🇬🇧Dorchester, England, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, England, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Darent Valley Hospital
🇬🇧Dartford Kent, England, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
St. George's Hospital
🇬🇧London, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
🇬🇧Guildford, England, United Kingdom
Cancer Research UK Clinical Groups at Guy's King's & St. Thomas' Hospitals
🇬🇧London, England, United Kingdom
Christie Hospital
🇬🇧Manchester, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, England, United Kingdom
Peterborough Hospitals Trust
🇬🇧Peterborough, England, United Kingdom
Torbay Hospital
🇬🇧Torquay Devon, England, United Kingdom
Royal Cornwall Hospital
🇬🇧Truro, Cornwall, England, United Kingdom
Wrexham Maelor Hospital
🇬🇧Wrexham, Wales, United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
🇬🇧Basingstoke, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
🇬🇧Brighton, England, United Kingdom
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
James Paget Hospital
🇬🇧Norfolk, England, United Kingdom
Salisbury District Hospital
🇬🇧Salisbury, England, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Worthing Hospital
🇬🇧Worthing, England, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, United Kingdom
James Cook University Hospital
🇬🇧Middlesbrough, England, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, England, United Kingdom
Dorset Cancer Centre
🇬🇧Poole Dorset, England, United Kingdom
Churchill Hospital
🇬🇧Oxford, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Portsmouth Oncology Centre at Saint Mary's Hospital
🇬🇧Portsmouth Hants, England, United Kingdom
Wexham Park Hospital
🇬🇧Slough, Berkshire, England, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, Scotland, United Kingdom
North Devon District Hospital
🇬🇧Barnstaple, 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
Royal Marsden - London
🇬🇧London, England, United Kingdom
Clatterbridge Centre for Oncology
🇬🇧Merseyside, England, United Kingdom
Conquest Hospital
🇬🇧Saint Leonards-on-Sea, England, United Kingdom
Yeovil District Hospital
🇬🇧Yeovil, England, United Kingdom
Glan Clwyd Hospital
🇬🇧Rhyl, Denbighshire, Wales, United Kingdom
Royal Liverpool University Hospital
🇬🇧Liverpool, England, United Kingdom