A prospective, phase III, controlled, multicentre, randomised clinical trial comparing combination gemcitabine and capecitabine therapy with concurent and sequential chemoimmunotherapy using a telomerase vaccine in locally advanced and metastatic pancreatic cancer

ISRCTN	ISRCTN43482138
DOI	https://doi.org/10.1186/ISRCTN43482138
ClinicalTrials.gov number	NCT00425360
Secondary identifying numbers	N/A

Submission date: 28/11/2005
Registration date: 14/12/2005
Last edited: 27/07/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-a-vaccine-called-gv1001-for-pancreatic-cancer-that-has-spread

Study website

Contact information

Dr Gary Middleton
Scientific

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

Study information

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
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A prospective, phase III, controlled, multicentre, randomised clinical trial comparing combination gemcitabine and capecitabine therapy with concurent and sequential chemoimmunotherapy using a telomerase vaccine in locally advanced and metastatic pancreatic cancer
Study acronym	TeloVac
Study objectives	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(s)	Ethical review pending
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	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 study start date	01/04/2006
Completion date	15/03/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	1100
Total final enrolment	1062
Key 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
Key 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
Date of first enrolment	01/04/2006
Date of final enrolment	15/03/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Surrey County Hospital

Guildford
GU2 7XX
United Kingdom

Sponsor information

The University of Liverpool (UK)
University/education

Research and Business Services
The Foresight Centre
1 Brownlow Street
Liverpool
L69 3GL
England
United Kingdom

Website	http://www.liv.ac.uk
"ROR"	https://ror.org/04xs57h96

Funders

Funder type

Charity

Cancer Research UK (C11497/A5690)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2014		Yes	No
Plain English results			27/07/2022	No	Yes

Editorial Notes

27/07/2022: Cancer Research UK plain English results summary link and total final enrolment added.