Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00425360
Protocol/serial number
N/A
Study information
Scientific title
Acronym
TeloVac
Study hypothesis
In patients with locally advanced or metastatic pancreatic adenocarcinoma, does the addition of telomerase vaccine GV1001, when given concurrently or sequentially, to combination gemcitabine and capecitabine, improve survival over treatment with combination gemcitabine and capecitabine alone.
Ethics approval
Ethical review pending
Study design
Phase III, prospective, open-label, controlled, multicentre, randomised clinical trial comparing combination gemcitabine and capcitabine with GV1001 in pancreatic cancer with follow-up.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Locally advanced and metastatic pancreatic cancer
Intervention
Arm 1 - Gemcitabine and capecitabine therapy: Gemcitabine will be administered on day one, eight and 15 followed by seven days rest. Per oral capecitabine will be administered morning and evening for 21 days followed by seven days rest. Gemcitabine and capecitabine therapy cycles will be repeated every four weeks until withdrawal from trial treatment.
Arm 2 - Gemcitabine and capecitabine then sequential GV1001 therapy: Patients will receive two cycles of combination gemcitabine and capecitabine before commencing GV1001 alone. Each of the two cycles of combination gemcitabine and capecitabine consists of:
Gemcitabine will be administered on day one, eight and 15 followed by seven days rest. Per oral Capecitabine will be administered morning and evening for 21 days followed by seven days rest. Following completion of gemcitabine and capecitabine therapy, GV1001 will be administered intradermally on Monday, Wednesday and Friday during week eight and once weekly during weeks nine, ten, 11, 13 and 17. Thereafter, vaccinations will follow a once monthly schedule until withdrawal from trial treatment.
Arm 3 - Concurrent Gemcitabine, Capecitabine and GV1001 therapy: Gemcitabine will be administered on day one, eight and 15 followed by seven days rest. Per oral Capecitabine will be administered morning and evening for 21 days followed by seven days rest. Gemcitabine and Capecitabine therapy cycles will be repeated every four weeks until withdrawal from trial treatment. GV1001 will be administered intradermally on Monday, Wednesday and Friday during week one followed by a once weekly schedule for weeks two, three, four, six and ten. Thereafter, GV1001 will be administered once monthly until withdrawal from trial treatment.
Intervention type
Drug
Phase
Phase III
Drug names
Gemcitabine, capecitabine and telomerase vaccine
Primary outcome measure
Length of survival
Secondary outcome measures
1. Time to Progression
2. Quality of life
3. Clinical Benefit Response
4. Objective response rates according to RECIST criteria
5. Toxicity
6. Survival and response according to Delayed Type Hypersensitivity
Overall trial start date
01/04/2006
Overall trial end date
15/03/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged over 18 years
2. Histologically or cytologically proven pancreatic ductal adenocarcinoma carcinoma
3. Locally advanced or metastatic disease precluding curative surgical resection
4. Contrast enhanced Computed Tomography (CT) scan of the thorax, abdomen and pelvis within 28 days of randomisation
5. Unidimensionally measurable disease (CT) in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines
6. World Health Organisation (WHO) performance status zero, one or two
7. Platelets more than 100 x 10^9/l; white blood cell count (WBC) more than 3 x 10^9/l; neutrophils more than 1.5 x 10^9/l at entry
8. Serum bilirubin less than 35 µmol/l
9. Calculated creatinine clearance over 50 ml/min
10. No concurrent uncontrolled medical condition
11. No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix
12. Life expectancy more than three months
13. Adequate contraceptive precautions if relevant
14. Informed written consent
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
1100
Participant exclusion criteria
1. Medical or psychiatric conditions compromising informed consent
2. Intracerebral metastases or meningeal carcinomatosis
3. Clinically significant serious disease or organ system disease not currently controlled on present therapy
4. Uncontrolled angina pectoris
5. Pregnancy or breast feeding
6. Treatment with chemotherapy, radiotherapy or other investigational drug within the last four weeks prior to inclusion
7. Known malabsorption syndromes
8. Patients with a known hypersensitivity to Fluorouracil (5-FU) or with a Dihydropyrimidine Dehydrogenase (DPD) deficiency
9. Immunosuppressive therapy less than four weeks prior to the start of treatment
10. People of child-bearing potential unless effective methods of contraception are used
Recruitment start date
01/04/2006
Recruitment end date
15/03/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Surrey County Hospital
Guildford
GU2 7XX
United Kingdom
Sponsor information
Organisation
The University of Liverpool (UK)
Sponsor details
Research and Business Services
The Foresight Centre
1 Brownlow Street
Liverpool
L69 3GL
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (C11497/A5690)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24954781
Publication citations
-
Results
Middleton G, Silcocks P, Cox T, Valle J, Wadsley J, Propper D, Coxon F, Ross P, Madhusudan S, Roques T, Cunningham D, Falk S, Wadd N, Harrison M, Corrie P, Iveson T, Robinson A, McAdam K, Eatock M, Evans J, Archer C, Hickish T, Garcia-Alonso A, Nicolson M, Steward W, Anthoney A, Greenhalf W, Shaw V, Costello E, Naisbitt D, Rawcliffe C, Nanson G, Neoptolemos J, Gemcitabine and capecitabine with or without telomerase peptide vaccine GV1001 in patients with locally advanced or metastatic pancreatic cancer (TeloVac): an open-label, randomised, phase 3 trial., Lancet Oncol., 2014, 15, 8, 829-840, doi: 10.1016/S1470-2045(14)70236-0.