Study Of Sunitinib In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer
NCT ID: NCT00555672
Last Updated: 2011-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
34 participants
INTERVENTIONAL
2008-08-31
2010-08-31
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
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
5-fluorouracil
5- fluorouracil is given as 4000 mg/m\^2 total dose over 96 hr continuous infusion of a 21 day chemotherapy cycle. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
cisplatin
Cisplatin is given 80 mg/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 37.5mg /day for 14 days followed by 7 days of drug free period. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
Interventions
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5-fluorouracil
5- fluorouracil is given as 4000 mg/m\^2 total dose over 96 hr continuous infusion of a 21 day chemotherapy cycle. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
cisplatin
Cisplatin is given 80 mg/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 37.5mg /day for 14 days followed by 7 days of drug free period. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
Eligibility Criteria
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Inclusion Criteria
* advanced stomach cancer stage IV
* adequate blood chemistry, blood counts and kidney function
* willing to participate to study requirements and to 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
Barcelona, Barcelona, Spain
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, Spain
Pfizer Investigational Site
Madrid, Madrid, Spain
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6181128
Identifier Type: -
Identifier Source: org_study_id