Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
NCT ID: NCT00032175
Last Updated: 2013-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
508 participants
INTERVENTIONAL
2002-04-30
2007-05-31
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or without capecitabine in treating patients who have locally advanced or metastatic pancreatic cancer.
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Detailed Description
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* 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.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 508 patients (254 per treatment arm) will be accrued for this study.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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capecitabine
gemcitabine hydrochloride
Eligibility Criteria
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Inclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Cancer Research UK
OTHER
Principal Investigators
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Emily Owen
Role:
Cancer Research UK
Locations
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Royal United Hospital
Bath, England, United Kingdom
Royal Bournemouth Hospital
Bournemouth, England, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom
Derbyshire Royal Infirmary
Derby, England, United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom
Ipswich Hospital NHS Trust
Ipswich, England, United Kingdom
Queen Elizabeth Hospital
Kings Lynn, England, United Kingdom
Cookridge Hospital at Leeds Teaching Hospital NHS Trust
Leeds, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Lincoln County Hospital
Lincoln, England, United Kingdom
Cancer Research UK Liverpool Cancer Trials Unit
Liverpool, England, United Kingdom
Royal Liverpool University Hospital
Liverpool, England, United Kingdom
St. Thomas' Hospital
London, England, United Kingdom
Christie Hospital NHS Trust
Manchester, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom
James Cook University Hospital at South Tees Hospitals NHS Trust
Middlesbrough, Cleveland, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Norfolk and Norwich University Hospital
Norwich, England, United Kingdom
Derriford Hospital
Plymouth, England, United Kingdom
Poole Hospital NHS Trust
Poole Dorset, England, United Kingdom
Whiston Hospital
Prescot Merseyside, England, United Kingdom
Royal Preston Hospital
Preston, England, United Kingdom
Salisbury District Hospital
Salisbury, England, United Kingdom
Royal South Hants Hospital
Southampton, England, United Kingdom
University Hospital of North Staffordshire
Stoke-on-Trent, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom
Warrington Hospital NHS Trust
Warrington, England, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Singleton Hospital of the Swansea NHS Trust
Swansea, Wales, United Kingdom
Countries
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References
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Cunningham D, Chau I, Stocken DD, Valle JW, Smith D, Steward W, Harper PG, Dunn J, Tudur-Smith C, West J, Falk S, Crellin A, Adab F, Thompson J, Leonard P, Ostrowski J, Eatock M, Scheithauer W, Herrmann R, Neoptolemos JP. Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer. J Clin Oncol. 2009 Nov 20;27(33):5513-8. doi: 10.1200/JCO.2009.24.2446. Epub 2009 Oct 26.
Other Identifiers
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CDR0000069263
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20116
Identifier Type: -
Identifier Source: secondary_id
ISRCTN11513444
Identifier Type: -
Identifier Source: secondary_id
CRUK-GEM-CAP
Identifier Type: -
Identifier Source: org_study_id
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