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| [ Print-friendly version ] |
| 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 |
| ClinicalTrials.gov identifier | |
| Public 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 |
| Scientific title | |
| Acronym | TeloVac |
| Serial number at source | N/A |
| 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 concurrent and sequential GV1001 in advanced and metastatic pancreatic cancer. Patients will be subject to follow-up for up to two-years upon disease progression as assessed by RECIST criteria. However the last patient subject to enrolment in the study will only be subject to one-year follow-up. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Locally advanced and metastatic pancreatic cancer |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/04/2006 |
| Anticipated end date | 31/03/2011 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 900 |
| Interventions |
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. |
| Primary outcome measure(s) | Length of survival |
| 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 |
| Sources of funding | Cancer Research UK (C11497/A5690) |
| Trial website | |
| Publications | |
| Contact name | Dr G. Middleton |
| Address |
Royal Surrey County Hospital Egerton Road |
| City/town | Guildford, Surrey |
| Zip/Postcode | GU2 7XX |
| Country | United Kingdom |
| Sponsor | The University of Liverpool (UK) |
| Address |
Research and Business Services The Foresight Centre 1 Brownlow Street |
| City/town | Liverpool |
| Zip/Postcode | L69 3GL |
| Country | United Kingdom |
| Sponsor website: | http://www.liv.ac.uk |
| Date applied | 28/11/2005 |
| Last edited | 23/08/2006 |
| Date ISRCTN assigned | 14/12/2005 |
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