Study Of Sunitinib In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer
NCT ID: NCT00555620
Last Updated: 2013-01-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
76 participants
INTERVENTIONAL
2008-05-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
capecitabine
Capecitabine is given orally at 1000mg/m\^2 twice a day for 14 days followed by 7 days of drug free period.
oxaliplatin
Oxaliplatin is given 110mg/m\^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
sunitinib malate
sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.
B
capecitabine
Capecitabine is given orally at 1000mg/m\^2 twice a day for 14 days followed by 7 days of drug free period.
cisplatin
Cisplatin is given 80mg/m\^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
sunitinib malate
sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.
Interventions
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capecitabine
Capecitabine is given orally at 1000mg/m\^2 twice a day for 14 days followed by 7 days of drug free period.
oxaliplatin
Oxaliplatin is given 110mg/m\^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
sunitinib malate
sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.
capecitabine
Capecitabine is given orally at 1000mg/m\^2 twice a day for 14 days followed by 7 days of drug free period.
cisplatin
Cisplatin is given 80mg/m\^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
sunitinib malate
sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* advanced stomach cancer of stage IV
* adequate blood chemistry, blood counts and kidney function
* willing to participate to study requirements and sign an informed consent document
Exclusion Criteria
* excessive toxicities related to prior therapies
* pregnant or breastfeeding patients
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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Pfizer Investigational Site
Goyang-si, Gyeonggi-do, South Korea
Pfizer Investigational Site
Seongnam-si, Gyeonggi-do, South Korea
Pfizer Investigational Site
Seoul, , South Korea
Countries
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References
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Lee KW, Park SR, Oh DY, Park YI, Khosravan R, Lin X, Lee SY, Roh EJ, Valota O, Lechuga MJ, Bang YJ. Phase I study of sunitinib plus capecitabine/cisplatin or capecitabine/oxaliplatin in advanced gastric cancer. Invest New Drugs. 2013 Dec;31(6):1547-58. doi: 10.1007/s10637-013-0032-y. Epub 2013 Oct 4.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6181126
Identifier Type: -
Identifier Source: org_study_id
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