TeloVac

Phase 1

• Conditions: Pancreatic cancer; MedDRA version: 16.1 Level: HLT Classification code 10033633 Term: Pancreatic neoplasms malignant (excl islet cell and carcinoid) System Organ Class: 100000004864

• Registration Number: EUCTR2006-000461-10-GB
• Lead Sponsor: The Royal Liverpool University Hospital NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-22
• Study Completion: 2012-05-27
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1062

Inclusion Criteria

1. Age > 18 years. 2. Histologically or cytologically proven pancreatic ductal adenocarcinoma carcinoma or undifferentiated carcinoma of the pancreas. 3. Locally advanced or metastatic disease precluding curative surgical resection. 4. Contrast enhanced CT scan of the thorax, abdomen and pelvis within 28 days prior to commencing treatment. 5. Unidimensionally measurable disease (CT) in accordance with the RECIST guidelines. 6. ECOG performance status 0, 1 or 2. 7. Platelets >100 x 109/l; WBC > 3 x 109/l; neutrophils > 1.5 x 109/l at entry. 8.Serum Bilirubin <35 micromol/l 9. Calculated creatinine clearance over 50ml/min according to Cockcroft & Gault. 10. Life expectancy > 3 months. 11. Informed written consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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. Previous chemotherapy. 7. Radiotherapy within the last 4 weeks prior to start of study treatment. 8. Concurrent malignancies or invasive cancers diagnosed within past 5 years except for adequately treated Basal Cell Carcinoma of the skin or in situ carcinoma of the uterine cervix 9. Known malabsorption syndromes. 10. Patients with a known hypersensitivity to any of the investigational products or patients with a dihydropyrimidine dehydrogenase (DPD) deficiency. 11. Medication which might affect immunocompetence e.g. chronic treatment with long term steroids or other immunosuppressant for an unrelated condition. Patients will be eligible if they have been receiving short term steroids for palliation of cancer related symptoms. 12. Chemotherapy directed at tumour apart from that described in this protocol. 13. All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified