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

Phase 3

Completed

• Conditions: Cancer; ocally advanced and metastatic pancreatic cancer; Locally advanced and metastatic pancreatic cancer

• Registration Number: ISRCTN43482138
• Lead Sponsor: The University of Liverpool (UK)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-14
• Study Completion: 2013-03-15
• Last Update Posted: 15 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1062

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ength of survival

Secondary Outcome Measures

Name	Time	Method
<br> 1. Time to Progression<br> 2. Quality of life<br> 3. Clinical Benefit Response<br> 4. Objective response rates according to RECIST criteria<br> 5. Toxicity<br> 6. Survival and response according to Delayed Type Hypersensitivity<br>