Study of Cediranib Plus Cisplatin Plus Capecitabine/S-1 in Japanese Gastric Cancer Patients
NCT ID: NCT00960349
Last Updated: 2011-06-14
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
PHASE1
14 participants
INTERVENTIONAL
2009-08-31
2011-03-31
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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Treatment A
Cediranib 20mg + Cisplatin + S-1
Cediranib
Given orally at a dose of 20mg/day everyday until the patient meets any discontinuation criterion.
Cisplatin
Given as a intravenous infusion at a dose of 80mg/m2 over 2hours on Day 1 of each cycle followed by a 5-week rest period. A maximum of 8 cycles of cisplatin will be given.
S-1
Given orally at a dose of 80 - 120mg/day according to BSA for 3 weeks followed by a 2-week rest period in each cycle. Will be continued indefinitely until the patient meets any discontinuation criterion.
Treatment B
Cediranib 20mg + Cisplatin + Capecitabine
Cediranib
Given orally at a dose of 20mg/day everyday until the patient meets any discontinuation criterion.
Cisplatin
60mg/m2 over 2hours on Day 1 of each cycle followed by a 5-week rest period. A maximum of 8 cycles of cisplatin will be given.
Capecitabine
Given orally at a dose of 1000mg/m2 twice daily for 2 weeks followed by a 1-week rest period in each cycle. Will be continued indefinitely until the patient meets any discontinuation criterion.
Interventions
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Cediranib
Given orally at a dose of 20mg/day everyday until the patient meets any discontinuation criterion.
Cisplatin
Given as a intravenous infusion at a dose of 80mg/m2 over 2hours on Day 1 of each cycle followed by a 5-week rest period. A maximum of 8 cycles of cisplatin will be given.
S-1
Given orally at a dose of 80 - 120mg/day according to BSA for 3 weeks followed by a 2-week rest period in each cycle. Will be continued indefinitely until the patient meets any discontinuation criterion.
Cisplatin
60mg/m2 over 2hours on Day 1 of each cycle followed by a 5-week rest period. A maximum of 8 cycles of cisplatin will be given.
Capecitabine
Given orally at a dose of 1000mg/m2 twice daily for 2 weeks followed by a 1-week rest period in each cycle. Will be continued indefinitely until the patient meets any discontinuation criterion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Having locally advanced or metastatic gastric cancer for which they must have received no prior systemic therapy for locally advanced disease. Previous gastrectomy, neoadjuvant and adjuvant therapy received \> 6 months ago are acceptable
* Having a mild symptom in ordinal daily lives including walking and simple labour or works in the sitting position
Exclusion Criteria
* Significant Haemorrhage (\> 30 ml bleeding/episode in previous 3 months) or haemoptysis (\> 5 ml fresh blood in previous 4 weeks)
* Arterial thromboembolic event (including ischemic attack) in the previous 12 months
20 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca
Principal Investigators
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Narikazu Boku, MD
Role: PRINCIPAL_INVESTIGATOR
Shizuoka Cancer Center, Japan
Locations
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Research Site
Nagoya, Aichi-ken, Japan
Research Site
Sayama, Osaka, Japan
Research Site
Sunto-gun, Shizuoka, Japan
Research Site
Chūō, Tokyo, Japan
Countries
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Other Identifiers
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D8480C00066
Identifier Type: -
Identifier Source: org_study_id
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