Gemcitabine With or Without Capecitabine 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, duct cell adenocarcinoma of the pancreas, stage IV pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed ductal adenocarcinoma of the pancreas Locally advanced or metastatic disease not amenable to curative surgical resection Macroscopic residual disease after prior resection with histological confirmation is allowed Unidimensionally measurable disease No intracerebral metastases or meningeal carcinomatosis PATIENT CHARACTERISTICS: Age: Over 18 Performance status: WHO 0-2 Life expectancy: More than 3 months Hematopoietic: WBC greater than 3,000/mm3 Neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2 mg/dL Renal: Creatinine less than 2 mg/dL Creatinine clearance greater than 50 mL/min Cardiovascular: No New York Heart Association class III or IV heart disease No uncontrolled angina pectoris Other: No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix No other concurrent uncontrolled medical condition No other medical or psychiatric condition that would preclude study No known hypersensitivity to fluorouracil No dihydropyrimidine dehydrogenase deficiency No known malabsorption syndromes Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy (including preoperative or adjuvant) for this disease No other concurrent cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy (including preoperative or adjuvant) for this disease Surgery: See Disease Characteristics Other: No prior investigational drugs (including preoperative or adjuvant) for this disease No other concurrent investigational drugs No concurrent dipyridamole or allopurinol No concurrent sorivudine or sorivudine analogs (e.g., brivudine) (capecitabine arm only)
Sites / Locations
- Royal United Hospital
- Royal Bournemouth Hospital
- Bristol Haematology and Oncology Centre
- Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
- Derbyshire Royal Infirmary
- Royal Devon and Exeter Hospital
- Ipswich Hospital NHS Trust
- Queen Elizabeth Hospital
- Cookridge Hospital at Leeds Teaching Hospital NHS Trust
- Leicester Royal Infirmary
- Lincoln County Hospital
- Cancer Research UK Liverpool Cancer Trials Unit
- Royal Liverpool University Hospital
- St. Thomas' Hospital
- Christie Hospital NHS Trust
- Clatterbridge Centre for Oncology NHS Trust
- James Cook University Hospital at South Tees Hospitals NHS Trust
- Northern Centre for Cancer Treatment at Newcastle General Hospital
- Norfolk and Norwich University Hospital
- Derriford Hospital
- Poole Hospital NHS Trust
- Whiston Hospital
- Royal Preston Hospital
- Salisbury District Hospital
- Royal South Hants Hospital
- University Hospital of North Staffordshire
- Royal Marsden NHS Foundation Trust - Surrey
- Warrington Hospital NHS Trust
- Aberdeen Royal Infirmary
- Singleton Hospital of the Swansea NHS Trust