AG-013736 In Combination With Gemcitabine Versus Gemcitabine Alone For Patients With Metastatic Pancreatic Cancer
NCT ID: NCT00219557
Last Updated: 2019-05-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
111 participants
INTERVENTIONAL
2005-07-05
2008-03-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Gemcitabine
Gemcitabine
Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks
Axitinib [AG-013736] plus gemcitabine
AG-013736
Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks.
Gemcitabine
Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Interventions
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Gemcitabine
Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks
AG-013736
Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks.
Gemcitabine
Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* no prior therapy for metastatic disease
Exclusion Criteria
* uncontrolled brain metastases (a controlled brain metastasis must be previously treated, asymptomatic, and without growth for 4 months)
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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East Bay Medical Oncology/Hematology Medical Associates Inc.
Antioch, California, United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States
Bay Area Cancer Research Group
Concord, California, United States
East Bay Medical Oncology/Hematology Medical Associates, Inc.
Concord, California, United States
Hematology Oncology, P.C.
Stamford, Connecticut, United States
Jackson Memorial Hospital & Clinics
Miami, Florida, United States
University of Miami Hospital & clinics
Miami, Florida, United States
H Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Maine Center for Cancer Medicine and Blood Disorders
Biddeford, Maine, United States
Maine Center for Cancer Medicine and Blood Disorders
Brunswick, Maine, United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, United States
Arch Medical Services, Inc. d/b/a The Center for Cancer Care and Research
St Louis, Missouri, United States
Arch Medical Services, Inc. d/b/a The Center for Cancer Care and Research
Washington, Missouri, United States
Southeast Nebraska Cancer Center, Southeast Nebraska Hematology and Oncology Consultants, P.C.
Lincoln, Nebraska, United States
Piedmont Hematology Oncology Association
Winston-Salem, North Carolina, United States
Piedmont Hematology Oncology Associates
Winston-Salem, North Carolina, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Universitair Ziekenhuis Gent/Dienst Gastroenterologie
Ghent, , Belgium
Cross Cancer Institute
Edmonton, Alberta, Canada
Cancer Care Manitoba
Winnipeg, Manitoba, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Sault Area Hospital
Sault Ste. Marie, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
CHUM, Hopital Saint-Luc
Montreal, Quebec, Canada
Service Oncologie Medicale
Saint-Herblain, Saint Herblain Cedex, France
Hopital La Timone
Marseille, , France
Hopital de la Pitie Salpetriere
Paris, , France
Institut Claudius Regaud
Toulouse, , France
Medizinische Klinik mit Schwerpunkt Haematologie und Onkologie, Charité-Universitaetsmedizin Berlin
Berlin, , Germany
Fondazione IRCCS, Istituto Nazionale Tumori, Oncologia Medica B
Milan, , Italy
Unita Operativa, Oncologia Medica, Istituto di Medicina Interna e Geriatria
Roma, , Italy
Hospital Universitario Vall D´Hebron
Barcelona, , Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Cancer Research Uk Clinical Centre
Southampton, Hampshire, United Kingdom
Department of Cancer Studies & Molecular Medicine
Leicester, Leicestershire, United Kingdom
Western General Hospitals Nhs Trust
Edinburgh, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Countries
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References
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Spano JP, Chodkiewicz C, Maurel J, Wong R, Wasan H, Barone C, Letourneau R, Bajetta E, Pithavala Y, Bycott P, Trask P, Liau K, Ricart AD, Kim S, Rixe O. Efficacy of gemcitabine plus axitinib compared with gemcitabine alone in patients with advanced pancreatic cancer: an open-label randomised phase II study. Lancet. 2008 Jun 21;371(9630):2101-8. doi: 10.1016/S0140-6736(08)60661-3. Epub 2008 May 29.
Related Links
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Other Identifiers
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2005-000053-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A4061016
Identifier Type: -
Identifier Source: org_study_id
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