Locally advanced and metastatic pancreatic cancer Cancer Locally advanced and metastatic pancreatic cancer
Conditions
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
Sponsors
The University of Liverpool (UK)
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed