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Sponsored by: |
Royal Liverpool University Hospital |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00425360 |
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.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Biological: sargramostim Biological: telomerase peptide vaccine GV1001 Drug: capecitabine Drug: gemcitabine hydrochloride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
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] |
Estimated Enrollment: | 1110 |
Study Start Date: | September 2006 |
OBJECTIVES:
Primary
Secondary
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent medications that could affect immunocompetence (e.g., chronic treatment with long-term steroids or other immunosuppressants for unrelated condition)
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
United Kingdom, England | |
Addenbrooke's Hospital | Recruiting |
Cambridge, England, United Kingdom, CB2 0QQ | |
Contact: Pippa Corrie, PhD, FRCP 44-1223-274-401 pippa.corrie@addenbrookes.nhs.uk | |
Basingstoke and North Hampshire NHS Foundation Trust | Recruiting |
Basingstoke, England, United Kingdom, RG24 9NA | |
Contact: Charlotte Rees, MD 44-125-631-4793 | |
Bristol Haematology and Oncology Centre | Recruiting |
Bristol, England, United Kingdom, BS2 8ED | |
Contact: Stephen J. Falk, MD 44-161-446-8102 stephen.falk@ubht.nhs.uk | |
Cancer Research Centre at Weston Park Hospital | Recruiting |
Sheffield, England, United Kingdom, S1O 2SJ | |
Contact: Jonathan Wadsley 44-114-226-5235 | |
Cancer Research UK Clinical Groups at Guy's King's & St. Thomas' Hospitals | Recruiting |
London, England, United Kingdom, SE5 9NU | |
Contact: Paul Ross 44-114-226-5235 | |
Christie Hospital | Recruiting |
Manchester, England, United Kingdom, M20 4BX | |
Contact: Juan W. Valle, MD 44-161-446-8102 juan.valle@christie-tr.nwest.nhs.uk | |
Churchill Hospital | Recruiting |
Oxford, England, United Kingdom, OX3 7LJ | |
Contact: Mark R. Middleton, MD, PhD, MBChB, MRCP 44-1865-226-186 mark.middleton@medonc.ox.ac.uk | |
Clatterbridge Centre for Oncology | Recruiting |
Merseyside, England, United Kingdom, CH63 4JY | |
Contact: David Smith, MD 44-151-334-1155 david.smith@ccotrust.nhs.uk | |
Conquest Hospital | Recruiting |
Saint Leonards-on-Sea, England, United Kingdom, TN37 7RD | |
Contact: Angus Robinson 44-1424-755-255 | |
Darent Valley Hospital | Recruiting |
Dartford Kent, England, United Kingdom, DA2 8DA | |
Contact: Contact Person 44-1322-428-500 | |
Nottingham City Hospital NHS Trust | Recruiting |
Nottingham, England, United Kingdom, NG5 1PB | |
Contact: Contact Person 44-115-969-1169 | |
Huddersfield Royal Infirmary | Recruiting |
Huddersfield, West Yorks, England, United Kingdom, HD3 3EA | |
Contact: Jo Dent 44-1484-342-000 | |
Ipswich Hospital | Recruiting |
Ipswich, England, United Kingdom, IP4 5PD | |
Contact: Contact Person 44-1473-712-233 | |
James Cook University Hospital | Recruiting |
Middlesbrough, England, United Kingdom, TS4 3BW | |
Contact: Contact Person 44-1642-850-850 | |
James Paget Hospital | Recruiting |
Norfolk, England, United Kingdom, NR31 6LA | |
Contact: Contact Person 44-1493-452-452 | |
Leicester Royal Infirmary | Recruiting |
Leicester, England, United Kingdom, LE1 5WW | |
Contact: William P. Steward, MD, PhD 44-1162-541-414 wps1@le.ac.uk | |
Mount Vernon Cancer Centre at Mount Vernon Hospital | Recruiting |
Northwood, England, United Kingdom, HA6 2RN | |
Contact: Contact Person 44-1923-826-111 | |
Norfolk and Norwich University Hospital | Recruiting |
Norwich, England, United Kingdom, NR4 7UY | |
Contact: M. J. Ostrowski 44-1603-287-225 | |
North Devon District Hospital | Recruiting |
Barnstaple, England, United Kingdom, EX31 4JB | |
Contact: Mark Napier, MD 44-1884-821-747 mark.napier@ndevon.swest.nhs.uk | |
Northern Centre for Cancer Treatment at Newcastle General Hospital | Recruiting |
Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE | |
Contact: Fareeda Coxon, MD 44-1912-738-811 fareeda.coxon@nuth.nhs.uk | |
Dorset County Hospital | Recruiting |
Dorchester, England, United Kingdom, DT1 2JY | |
Contact: Richard Osborne, MD, FRCP 44-1305-251-150 | |
Peterborough Hospitals Trust | Recruiting |
Peterborough, England, United Kingdom, PE3 6DA | |
Contact: Karen E. McAdam, MD 44-1733-874-255 | |
Pilgrim Hospital | Recruiting |
Boston, England, United Kingdom, PE21 9QT | |
Contact: Zuzana Stokes 44-1205-364-801 | |
Poole Hospital NHS Trust | Recruiting |
Poole Dorset, England, United Kingdom, BH15 2JB | |
Contact: Richard Osborne, MD, FRCP 44-1-202-448-265 | |
Portsmouth Oncology Centre at Saint Mary's Hospital | Recruiting |
Portsmouth Hants, England, United Kingdom, PO3 6AD | |
Contact: Caroline Archer, MD 44-23-9228-6000 ext. 2363 | |
Royal Bournemouth Hospital NHS Trust | Recruiting |
Bournemouth, England, United Kingdom, BH7 7DW | |
Contact: Tamas Hickish, MD 44-1201-303-626 tamas.hickish@rbch.nhs.uk | |
Royal Cornwall Hospital | Recruiting |
Truro, Cornwall, England, United Kingdom, TR1 3LJ | |
Contact: Contact Person 44-1872-250-000 | |
Saint Bartholomew's Hospital | Recruiting |
London, England, United Kingdom, EC1A 7BE | |
Contact: David Propper, MD 44-207-601-7460 d.j.propper@qmul.ac.uk | |
Royal Liverpool University Hospital | Recruiting |
Liverpool, England, United Kingdom, L7 8XP | |
Contact: David Smith, MD 44-151-706-4170 | |
Royal Marsden - London | Recruiting |
London, England, United Kingdom, SW3 6JJ | |
Contact: David Cunningham, MD 44-20-8661-3156 | |
Royal Marsden - Surrey | Recruiting |
Sutton, England, United Kingdom, SM2 5PT | |
Contact: David Cunningham, MD 44-2086-613-156 david.cunningham@rmh.nhs.uk | |
Royal Devon and Exeter Hospital | Recruiting |
Exeter, England, United Kingdom, EX2 5DW | |
Contact: Contact Person 44-1392-411-611 | |
Salisbury District Hospital | Recruiting |
Salisbury, England, United Kingdom, SP2 8BJ | |
Contact: Tim J. Iveson, MD 44-1722-336-262 ext. 4688 | |
St. Luke's Cancer Centre at Royal Surrey County Hospital | Recruiting |
Guildford, England, United Kingdom, GU2 7XX | |
Contact: Gary W. Middleton 44-1483-570-122 gmiddleton@royalsurrey.nhs.uk | |
Sussex Cancer Centre at Royal Sussex County Hospital | Recruiting |
Brighton, England, United Kingdom, BN2 5BE | |
Contact: Andrew Webb, MD 44-1273-696-955 x 4600 | |
Torbay Hospital | Recruiting |
Torquay Devon, England, United Kingdom, TQ2 7AA | |
Contact: Contact Person 44-1803-614-567 | |
Wexham Park Hospital | Recruiting |
Slough, Berkshire, England, United Kingdom, SL2 4HL | |
Contact: Marcia Hall, MD 44-1753-634-364 marcia.hall@nhs.net.uk | |
Worthing Hospital | Recruiting |
Worthing, England, United Kingdom, BN11 2DH | |
Contact: Andrew Webb, MD 44-1903-205-111 | |
Yeovil District Hospital | Recruiting |
Yeovil, England, United Kingdom, BA21 4AT | |
Contact: Stephen J. Falk, MD 44-1935-475-122 stephen.falk@swest.uhs.uk | |
United Kingdom, Scotland | |
Aberdeen Royal Infirmary | Recruiting |
Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
Contact: Marianne C. Nicolson, MD 44-1224-553-500 | |
Beatson West of Scotland Cancer Centre | Recruiting |
Glasgow, Scotland, United Kingdom, G11 6NT | |
Contact: Jeffry Evans, MD 44-141-211-1741 j.evans@beatson.gla.ac.uk | |
United Kingdom, Wales | |
Glan Clwyd Hospital | Recruiting |
Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ | |
Contact: Contact Person 44-1745-583-910 | |
Wrexham Maelor Hospital | Recruiting |
Wrexham, Wales, United Kingdom, LL13 7TD | |
Contact: Simon Gollins, MD 44-1978-291-100 |
Study Chair: | Gary W. Middleton | St. Luke's Cancer Centre at Royal Surrey County Hospital |
Study ID Numbers: | CDR0000528021, CRUK-TELOVAC-V4, EUDRACT-2006-000461-10, EU-20683, ISRTCN43482138 |
Study First Received: | January 19, 2007 |
Last Updated: | May 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00425360 History of Changes |
Health Authority: | Unspecified |
stage III pancreatic cancer stage IV pancreatic cancer duct cell adenocarcinoma of the pancreas recurrent pancreatic cancer |
Antimetabolites Anti-Infective Agents Capecitabine Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Endocrine System Diseases Immunosuppressive Agents Antiviral Agents Pancrelipase |
Recurrence Digestive System Diseases Radiation-Sensitizing Agents Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Capecitabine Digestive System Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Endocrine System Diseases Enzyme Inhibitors |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Radiation-Sensitizing Agents Therapeutic Uses Pancreatic Diseases Gemcitabine Endocrine Gland Neoplasms |