Gemcitabine and Capecitabine With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00425360
First received: January 19, 2007
Last updated: August 23, 2013
Last verified: May 2009
  Purpose

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
Pancreatic Cancer
Biological: sargramostim
Biological: telomerase peptide vaccine GV1001
Drug: capecitabine
Drug: gemcitabine hydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
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]

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Survival at 1 year [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Clinical benefit response [ Designated as safety issue: No ]
  • Objective response rate as assessed by RECIST criteria [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE version 3 [ Designated as safety issue: Yes ]
  • Survival and response as assessed by delayed-type hypersensitivity [ Designated as safety issue: No ]

Estimated Enrollment: 1110
Study Start Date: September 2006
Study Completion Date: March 2013
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425360

Locations
United Kingdom
North Devon District Hospital
Barnstaple, England, United Kingdom, EX31 4JB
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom, RG24 9NA
Pilgrim Hospital
Boston, England, United Kingdom, PE21 9QT
Royal Bournemouth Hospital
Bournemouth, England, United Kingdom, BH7 7DW
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom, BN2 5BE
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 0QQ
Darent Valley Hospital
Dartford Kent, England, United Kingdom, DA2 8DA
Dorset County Hospital
Dorchester, England, United Kingdom, DT1 2JY
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom, EX2 5DW
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, United Kingdom, GU2 7XX
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, United Kingdom, HD3 3EA
Ipswich Hospital
Ipswich, England, United Kingdom, IP4 5PD
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Royal Liverpool University Hospital
Liverpool, England, United Kingdom, L7 8XP
Royal Marsden - London
London, England, United Kingdom, SW3 6JJ
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Cancer Research UK Clinical Groups at Guy's King's & St. Thomas' Hospitals
London, England, United Kingdom, SE5 9NU
St. George's Hospital
London, England, United Kingdom, SW17 0QT
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom, CH63 4JY
James Cook University Hospital
Middlesbrough, England, United Kingdom, TS4 3BW
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE
James Paget Hospital
Norfolk, England, United Kingdom, NR31 6LA
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
Norfolk and Norwich University Hospital
Norwich, England, United Kingdom, NR4 7UY
Nottingham City Hospital
Nottingham, England, United Kingdom, NG5 1PB
Churchill Hospital
Oxford, England, United Kingdom, OX3 7LJ
Peterborough Hospitals Trust
Peterborough, England, United Kingdom, PE3 6DA
Dorset Cancer Centre
Poole Dorset, England, United Kingdom, BH15 2JB
Portsmouth Oncology Centre at Saint Mary's Hospital
Portsmouth Hants, England, United Kingdom, PO3 6AD
Conquest Hospital
Saint Leonards-on-Sea, England, United Kingdom, TN37 7RD
Salisbury District Hospital
Salisbury, England, United Kingdom, SP2 8BJ
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom, S10 2SJ
Wexham Park Hospital
Slough, Berkshire, England, United Kingdom, SL2 4HL
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Torbay Hospital
Torquay Devon, England, United Kingdom, TQ2 7AA
Royal Cornwall Hospital
Truro, Cornwall, England, United Kingdom, TR1 3LJ
Worthing Hospital
Worthing, England, United Kingdom, BN11 2DH
Yeovil District Hospital
Yeovil, England, United Kingdom, BA21 4AT
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
Wrexham Maelor Hospital
Wrexham, Wales, United Kingdom, LL13 7TD
Sponsors and Collaborators
Royal Liverpool University Hospital
Investigators
Study Chair: Gary W. Middleton St. Luke's Cancer Centre at Royal Surrey County Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00425360     History of Changes
Other Study ID Numbers: CDR0000528021, CRUK-TELOVAC-V4, EUDRACT-2006-000461-10, EU-20683, ISRTCN43482138
Study First Received: January 19, 2007
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage III pancreatic cancer
stage IV pancreatic cancer
duct cell adenocarcinoma of the pancreas
recurrent pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 19, 2014