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 (NCT) NCT00425360
Protocol serial number N/A
Sponsor The University of Liverpool (UK)
Funder Cancer Research UK (C11497/A5690)
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

Contact information

Dr Gary Middleton
Scientific

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

Study information

Primary study designInterventional
Study designPhase III, prospective, open-label, controlled, multicentre, randomised clinical trial comparing combination gemcitabine and capcitabine with GV1001 in pancreatic cancer with follow-up.
Secondary study designRandomised controlled trial
Scientific titleA 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 acronymTeloVac
Study objectivesIn 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) studiedLocally advanced and metastatic pancreatic cancer
InterventionArm 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 typeDrug
PhasePhase III
Drug / device / biological / vaccine name(s)Gemcitabine, capecitabine and telomerase vaccine
Primary outcome measure(s)

Length of survival

Key secondary outcome measure(s)

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

Completion date15/03/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Sex
Target sample size at registration1100
Total final enrolment1062
Key inclusion criteria1. 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 criteria1. 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 enrolment01/04/2006
Date of final enrolment15/03/2013

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Royal Surrey County Hospital
Guildford
GU2 7XX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing planNot 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
Study website Study website 11/11/2025 11/11/2025 No Yes

Editorial Notes

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

BMC - Part of Springer Nature Springer Nature