Condition category
Cancer
Date applied
28/11/2005
Date assigned
14/12/2005
Last edited
27/06/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Gary Middleton

ORCID ID

Contact details

Royal Surrey County Hospital
Egerton Road
Guildford
GU2 7XX
United Kingdom

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 measures

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

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

http://www.liv.ac.uk

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24954781

Publication citations

  1. 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.

Additional files

Editorial Notes