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Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer Clinical research trials and Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer. Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "G" Clinical Trials Conditions > Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer  Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
For Condition: duct cell adenocarcinoma of the pancreas,stage 4A pancreatic cancer,stage 3 pancreatic cancer,stage 4B pancreatic cancer
Status: Recruiting
Sponsor(s): Cancer Research UK ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if gemcitabine is more effective with or without capecitabine in treating pancreatic cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of gemcitabine with or without capecitabine in treating patients who have locally advanced or metastatic pancreatic cancer.
Details: OBJECTIVES: - Compare the 1-year survival rate of patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine with or without capecitabine. - Compare the median and 2-year survival rates and the objective response rates of patients treated with these regimens. - Compare the toxicity of these regimens in these patients. - Compare the quality of life of patients treated with these regimens. OUTLINE: This is an randomized, open-label, multicenter study. Patients are stratified according to disease stage (locally advanced vs metastatic) and performance status (0 and 1 vs 2). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43 during the first course. After a 1-week rest period, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Subsequent courses repeat every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 3 months for 1 year, and then annually thereafter. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 508 patients (254 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HelenHickey, Study Chair, Cancer Research UK - Trials Office
Salisbury District Hospital *Recruiting*
Salisbury, England, SP2 8BJ
United Kingdom
Recruiting Tim Iveson 44-1722-336-262 ext. 4688
Addenbrooke's NHS Trust *Recruiting*
Cambridge, England, CB2 2QQ
United Kingdom
Recruiting Philippa Corrie 44-1223-274-376
Warrington Hospital NHS Trust *Recruiting*
Warrington, England, WA5 1QG
United Kingdom
Recruiting P. Clark 44-1925-635-911
Singleton Hospital *Recruiting*
Swansea, Wales, SA 2 8QA
United Kingdom
Recruiting Gajek 44-1792-205-666
University of Liverpool *Recruiting*
Liverpool, England, L69 3GA
United Kingdom
Recruiting John Neoptolemos 44-151-706-4175
Aberdeen Royal Infirmary *Recruiting*
Aberdeen, Scotland, AB25 2ZN
United Kingdom
Recruiting M. Nicolson 44-1224-681-818
Royal United Hospital *Recruiting*
Bath, England, BA1 3NG
United Kingdom
Recruiting E. Gilby 44-1225-824-317
Royal Devon and Exeter Hospital *Recruiting*
Exeter, England, EX2 5DW
United Kingdom
Recruiting Mark Napier 44-1392-411-611
Norfolk and Norwich University Hospital *Recruiting*
Norwich, England, NR4 7UY
United Kingdom
Recruiting M.J. Ostrowski 44-603-286-286
Queen Elizabeth Hospital *Recruiting*
King's Lynn, England, PE30 4ET
United Kingdom
Recruiting Athar Ahmad 44-1553-613-684
Guy's and St. Thomas' Hospitals NHS Trust *Recruiting*
London, England, SE1 9RT
United Kingdom
Recruiting Peter Harper 44-20-7955-2933
Leicester Royal Infirmary *Recruiting*
Leicester, England, LE1 5WW
United Kingdom
Recruiting William Steward 44-116-258-7597
Northern Centre for Cancer Treatment at Newcastle General Hospital *Recruiting*
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
Recruiting F. Coxon 44-191-219-4208
Cancer Research UK - Trials Office *Recruiting*
Liverpool, England, L 69 3GA
United Kingdom
Recruiting Helen Hickey 00 44 151 706-4029
Royal Marsden Hospital - Sutton *Recruiting*
Sutton, England, SM2 5PT
United Kingdom
Recruiting David Cunningham 44-208-642-6011
Clatterbridge Centre for Oncology NHS Trust *Recruiting*
Merseyside, England, CH63 4JY
United Kingdom
Recruiting David Smith 44-151-334-1155
Ipswich Hospital NHS Trust *Recruiting*
Ipswich, England, IP4 5PD
United Kingdom
Recruiting Sudha Bulusu 44-1473-712-233
Lincoln County Hospital *Recruiting*
Lincoln, England, LN2 5QY
United Kingdom
Recruiting Thomas Sheehan 44-1522-573-965
North Staffs Royal Infirmary *Recruiting*
Stoke on Trent, England, ST4 7LN
United Kingdom
Recruiting F. Adab 01782-554176
Whiston Hospital *Recruiting*
Prescot Merseyside, England, L35 5DR
United Kingdom
Recruiting Ernest Marshall 0151-426-1600
Cookridge Hospital at Leeds Teaching Hospital NHS Trust *Recruiting*
Leeds, England, LS16 6QB
United Kingdom
Recruiting A. Crellin 44-113-392-4475
Poole Hospital NHS Trust *Recruiting*
Poole Dorset, England, BH15 2JB
United Kingdom
Recruiting R. Osborne 441-202-448-265
James Cook University Hospital *Recruiting*
Middlesbrough, England, TS4 3BW
United Kingdom
Recruiting N. Wadd 44-1642-850-850
Bristol Haematology and Oncology Centre *Recruiting*
Bristol, England, BS2 8ED
United Kingdom
Recruiting Stephen Falk 44-117-928-2412
Royal Preston Hospital *Recruiting*
Preston, England, PR2 9HT
United Kingdom
Recruiting Shabbir Susnerwala 01772-522-909
Royal Bournemouth Hospital *Recruiting*
Bournemouth, England, BH7 7DW
United Kingdom
Recruiting Tamas Hickish 44-1202-704789
Derriford Hospital *Recruiting*
Plymouth, England, PL6 8DH
United Kingdom
Recruiting Francis Daniel 44-1752-763-993
Derbyshire Royal Infirmary *Recruiting*
Derby, England, DE1 2QY
United Kingdom
Recruiting R. Kulkarni 01332-347141 ext. 4562
Christie Hospital N.H.S. Trust *Recruiting*
Manchester, England, M20 4BX
United Kingdom
Recruiting Robert Hawkins 44-161-446-3000
Royal South Hants Hospital *Recruiting*
Southampton, England, SO14 0YG
United Kingdom
Recruiting Christopher Baughan 44-23-8063-4288
Additional Information:
Study ID Numbers: CDR0000069263; CRUK-GEM-CAP,EU-20116
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032175
Other Stage 4b Pancreatic Cancer Studies:
1. DHA-Paclitaxel With or Without Gemcitabine in Treating Patients With Advanced Solid Tumors or Unresectable Pancreatic Cancer
2. Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
3. Cisplatin, Metronomic Low-Dose Interferon alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer
4. Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic Pancreatic Cancer
5. BMS-247550 in Treating Patients With Advanced Pancreatic Cancer
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Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
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