Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

Primary

1. 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

1. Determine the safety of this regimen in these patients.
2. Assess the immunogenicity of this regimen in these patients.
3. Determine the time to progression in patients treated with this regimen.
4. Determine the quality of life of patients treated with this regimen.
5. Determine the clinical benefit response in patients treated with this regimen.
6. Determine the objective response rate in patients treated with this regimen.
7. Determine the toxicity of this regimen in these patients.
8. Determine the survival and response by delayed-type hypersensitivity in patients treated with this regimen.

Entry 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

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

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

Expected Enrollment

A total of 1,110 patients will be accrued for this study.

Outcomes

Survival at 1 year

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

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

Trial Contact Information

Trial Lead Organizations

Royal Liverpool University Hospital

Gary Middleton, Protocol chair		Ph: 44-1483-570-122 Email: gmiddleton@royalsurrey.nhs.uk

United Kingdom
England
	Barnstaple
	North Devon District Hospital
		Mark Napier, MD	Ph:  44-1884-821-747
			Email: mark.napier@ndevon.swest.nhs.uk
	Basingstoke
	Basingstoke and North Hampshire NHS Foundation Trust
		Charlotte Rees, MD	Ph:  44-125-631-4793
	Boston
	Pilgrim Hospital
		Zuzana Stokes	Ph:  44-1205-364-801
	Bournemouth
	Royal Bournemouth Hospital
		Tamas Hickish, MD	Ph:  44-1201-303-626
			Email: tamas.hickish@rbch.nhs.uk
	Brighton
	Sussex Cancer Centre at Royal Sussex County Hospital
		Andrew Webb, MD	Ph:  44-1273-696-955 x 4600
	Bristol
	Bristol Haematology and Oncology Centre
		Stephen Falk, MD	Ph:  44-161-446-8102
			Email: stephen.falk@ubht.nhs.uk
	Cambridge
	Addenbrooke's Hospital
		Pippa Corrie, PhD, FRCP	Ph:  44-1223-274-401
			Email: pippa.corrie@addenbrookes.nhs.uk
	Dartford Kent
	Darent Valley Hospital
		Contact Person	Ph:  44-1322-428-500
	Dorchester
	Dorset County Hospital
		Richard Osborne, MD, FRCP	Ph:  44-1305-251-150
	Exeter
	Royal Devon and Exeter Hospital
		Contact Person	Ph:  44-1392-411-611
	Guildford
	St. Luke's Cancer Centre at Royal Surrey County Hospital
		Gary Middleton	Ph:  44-1483-570-122
			Email: gmiddleton@royalsurrey.nhs.uk
	Huddersfield, West Yorks
	Huddersfield Royal Infirmary
		Jo Dent	Ph:  44-1484-342-000
	Ipswich
	Ipswich Hospital
		Contact Person	Ph:  44-1473-712-233
	Leeds
	Leeds Cancer Centre at St. James's University Hospital
		D. Allan Anthoney, MD	Ph:  44-113-267-3411
			Email: danthoney@nhs.net
	Leicester
	Leicester Royal Infirmary
		William Steward, MD, PhD	Ph:  44-1162-541-414
			Email: wps1@le.ac.uk
	Liverpool
	Royal Liverpool University Hospital
		David Smith, MD	Ph:  44-151-706-4170
	London
	Cancer Research UK Clinical Groups at Guy's King's & St. Thomas' Hospitals
		Paul Ross	Ph:  44-114-226-5235
	Royal Marsden - London
		David Cunningham, MD	Ph:  44-20-8661-3156
	Saint Bartholomew's Hospital
		David Propper, MD	Ph:  44-207-601-7460
			Email: d.j.propper@qmul.ac.uk
	St. George's Hospital
		Tim Benepal, MD	Ph:  44-208-725-2995
	Manchester
	Christie Hospital
		Juan Valle, MD	Ph:  44-161-446-8102
			Email: juan.valle@christie-tr.nwest.nhs.uk
	Merseyside
	Clatterbridge Centre for Oncology
		David Smith, MD	Ph:  44-151-334-1155
			Email: david.smith@ccotrust.nhs.uk
	Middlesbrough
	James Cook University Hospital
		Contact Person	Ph:  44-1642-850-850
	Newcastle-Upon-Tyne
	Northern Centre for Cancer Treatment at Newcastle General Hospital
		Fareeda Coxon, MD	Ph:  44-1912-738-811
			Email: fareeda.coxon@nuth.nhs.uk
	Norfolk
	James Paget Hospital
		Contact Person	Ph:  44-1493-452-452
	Northwood
	Mount Vernon Cancer Centre at Mount Vernon Hospital
		Contact Person	Ph:  44-1923-826-111
	Norwich
	Norfolk and Norwich University Hospital
		M. J. Ostrowski	Ph:  44-1603-287-225
	Nottingham
	Nottingham City Hospital
		Contact Person	Ph:  44-115-969-1169
	Oxford
	Churchill Hospital
		Mark Middleton, MD, PhD, MBChB, MRCP	Ph:  44-1865-226-186
			Email: mark.middleton@medonc.ox.ac.uk
	Peterborough
	Peterborough Hospitals Trust
		Karen McAdam, MD	Ph:  44-1733-874-255
	Poole Dorset
	Dorset Cancer Centre
		Richard Osborne, MD, FRCP	Ph:  44-1-202-448-265
	Portsmouth Hants
	Portsmouth Oncology Centre at Saint Mary's Hospital
		Caroline Archer, MD	Ph:  44-23-9228-6000 ext. 2363
	Saint Leonards-on-Sea
	Conquest Hospital
		Angus Robinson	Ph:  44-1424-755-255
	Salisbury
	Salisbury District Hospital
		Tim Iveson, MD	Ph:  44-1722-336-262 ext. 4688
	Sheffield
	Cancer Research Centre at Weston Park Hospital
		Jonathan Wadsley	Ph:  44-114-226-5235
	Slough, Berkshire
	Wexham Park Hospital
		Marcia Hall, MD	Ph:  44-1753-634-364
			Email: marcia.hall@nhs.net.uk
	Sutton
	Royal Marsden - Surrey
		David Cunningham, MD	Ph:  44-2086-613-156
			Email: david.cunningham@rmh.nhs.uk
	Torquay Devon
	Torbay Hospital
		Contact Person	Ph:  44-1803-614-567
	Truro, Cornwall
	Royal Cornwall Hospital
		Contact Person	Ph:  44-1872-250-000
	Worthing
	Worthing Hospital
		Andrew Webb, MD	Ph:  44-1903-205-111
	Yeovil
	Yeovil District Hospital
		Stephen Falk, MD	Ph:  44-1935-475-122
			Email: stephen.falk@swest.uhs.uk
Scotland
	Aberdeen
	Aberdeen Royal Infirmary
		Marianne Nicolson, MD	Ph:  44-1224-553-500
	Glasgow
	Beatson West of Scotland Cancer Centre
		Jeffry Evans, MD	Ph:  44-141-211-1741
			Email: j.evans@beatson.gla.ac.uk
Wales
	Rhyl, Denbighshire
	Glan Clwyd Hospital
		Contact Person	Ph:  44-1745-583-910
	Wrexham
	Wrexham Maelor Hospital
		Simon Gollins, MD	Ph:  44-1978-291-100

Registry Information
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]
Trial Start Date		2006-09-01
Registered in ClinicalTrials.gov		NCT00425360
Date Submitted to PDQ		2006-12-19
Information Last Verified		2009-05-11

Back to Top