Gemcitabine and Capecitabine With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Pancreatic Cancer

About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage III pancreatic cancer, stage IV pancreatic cancer, duct cell adenocarcinoma of the pancreas, recurrent pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
- Locally advanced or metastatic disease precluding curative surgical resection
- Unidimensionally measurable disease by CT scan
- No intracerebral metastases or meningeal carcinomatosis
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 3 months
- WBC > 3,000/mm³
- Absolute neutrophil count > 1,500/mm³
- Platelet count > 100,000/mm³
- Bilirubin < 2.0 mg/dL
- Creatinine clearance > 50 mL/min
- No medical or psychiatric condition that would preclude giving informed consent
- No clinically significant serious disease or organ system disease not currently controlled on present therapy
- No uncontrolled angina pectoris
- Not pregnant or nursing
- Fertile patients must use a condom and ≥ 1 other form of contraception during and for 1 year after completion of study treatment
- No other malignancies or invasive cancers within the past 5 years except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
- No known malabsorption syndrome
- No known hypersensitivity to any of the investigational agents
- No dihydropyrimidine dehydrogenase deficiency
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy
- No radiotherapy within the past 4 weeks
No concurrent medications that could affect immunocompetence (e.g., chronic treatment with long-term steroids or other immunosuppressants for unrelated condition)
- Concurrent short-term steroids for palliation of cancer-related symptoms allowed
- No other concurrent investigational drugs or cytotoxic agents
No other concurrent immunotherapy (e.g., immunosuppressants or chronic use of systemic corticosteroids) or chemotherapy for another tumor in patients receiving telomerase peptide vaccine GV1001
- Concurrent low-dose corticosteroids may be allowed
Sites / Locations
- North Devon District Hospital
- Basingstoke and North Hampshire NHS Foundation Trust
- Pilgrim Hospital
- Royal Bournemouth Hospital
- Sussex Cancer Centre at Royal Sussex County Hospital
- Bristol Haematology and Oncology Centre
- Addenbrooke's Hospital
- Darent Valley Hospital
- Dorset County Hospital
- Royal Devon and Exeter Hospital
- St. Luke's Cancer Centre at Royal Surrey County Hospital
- Huddersfield Royal Infirmary
- Ipswich Hospital
- Leeds Cancer Centre at St. James's University Hospital
- Leicester Royal Infirmary
- Royal Liverpool University Hospital
- Saint Bartholomew's Hospital
- Cancer Research UK Clinical Groups at Guy's King's & St. Thomas' Hospitals
- St. George's Hospital
- Royal Marsden - London
- Christie Hospital
- Clatterbridge Centre for Oncology
- James Cook University Hospital
- Northern Centre for Cancer Treatment at Newcastle General Hospital
- James Paget Hospital
- Mount Vernon Cancer Centre at Mount Vernon Hospital
- Norfolk and Norwich University Hospital
- Nottingham City Hospital
- Churchill Hospital
- Peterborough Hospitals Trust
- Dorset Cancer Centre
- Portsmouth Oncology Centre at Saint Mary's Hospital
- Conquest Hospital
- Salisbury District Hospital
- Cancer Research Centre at Weston Park Hospital
- Wexham Park Hospital
- Royal Marsden - Surrey
- Torbay Hospital
- Royal Cornwall Hospital
- Worthing Hospital
- Yeovil District Hospital
- Aberdeen Royal Infirmary
- Beatson West of Scotland Cancer Centre
- Glan Clwyd Hospital
- Wrexham Maelor Hospital