A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer.
NCT ID: NCT00454636
Last Updated: 2016-09-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
158 participants
INTERVENTIONAL
2007-03-31
2010-07-31
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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Cisplatin / Capecitabine
Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
Cisplatin
80 mg/m2/day, intravenous (IV), every 3 weeks
Capecitabine
1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle
Epirubicin / Cisplatin / Capecitabine
Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks.
Epirubicin
50 mg/m2/day, IV, every 3 weeks
Cisplatin
60 mg/m2/day, IV, every 3 weeks
Capecitabine
625 mg/m2, oral, twice daily per 3-week cycle
Epirubicin / Oxaliplatin / Capecitabine
Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks.
Epirubicin
50 mg/m2/day, IV, every 3 weeks
Capecitabine
625 mg/m2, oral, twice daily per 3-week cycle
Oxaliplatin
130 mg/m2/day, IV, every 3 weeks
Docetaxel / Cisplatin / Capecitabine
Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
Cisplatin
60 mg/m2/day, IV, every 3 weeks
Docetaxel
60 mg/m2/day, IV, every 3 weeks
Capecitabine
825 mg/m2, oral, twice daily for 2 weeks
Interventions
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Cisplatin
80 mg/m2/day, intravenous (IV), every 3 weeks
Capecitabine
1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle
Epirubicin
50 mg/m2/day, IV, every 3 weeks
Cisplatin
60 mg/m2/day, IV, every 3 weeks
Capecitabine
625 mg/m2, oral, twice daily per 3-week cycle
Oxaliplatin
130 mg/m2/day, IV, every 3 weeks
Docetaxel
60 mg/m2/day, IV, every 3 weeks
Capecitabine
825 mg/m2, oral, twice daily for 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* advanced or metastatic gastric cancer;
* Eastern Cooperative Oncology Group (ECOG) \<=2.
Exclusion Criteria
* evidence of central nervous system (CNS) metastasis;
* history of another malignancy within the last 5 years (except for successfully treated basal cell cancer of skin, or in situ cancer of the cervix);
* clinically significant cardiac disease.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Alcoy, Alicante, Spain
Ávila, Avila, Spain
Palma de Mallorca, Balearic Islands, Spain
Palma de Mallorca, Balearic Islands, Spain
Barcelona, Barcelona, Spain
Burgos, Burgos, Spain
Cadiz, Cadiz, Spain
Jerez de la Frontera, Cadiz, Spain
Puerto Real, Cadiz, Spain
Castellon, Castellon, Spain
Córdoba, Cordoba, Spain
Girona, Girona, Spain
Granada, Granada, Spain
Granada, Granada, Spain
Guadalajara, Guadalajara, Spain
Donostia / San Sebastian, Guipuzcoa, Spain
Barbastro, Huesca, Spain
Huesca, Huesca, Spain
Jaén, Jaen, Spain
A Coruña, La Coruña, Spain
A Coruña, La Coruña, Spain
Ferrol, La Coruña, Spain
Santiago de Compostela, La Coruña, Spain
Logroño, La Rioja, Spain
León, Leon, Spain
Lleida, Lerida, Spain
Lugo, Lugo, Spain
Alcorcón, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Murcia, Murcia, Spain
Navarra, Navarre, Spain
Pamplona, Navarre, Spain
Ourense, Orense, Spain
Palencia, Palencia, Spain
Pontevedra, Pontevedra, Spain
Vigo, Pontevedra, Spain
Gijón, Principality of Asturias, Spain
Salamanca, Salamanca, Spain
Seville, Sevilla, Spain
San Cristóbal de La Laguna, Tenerife, Spain
Toledo, Toledo, Spain
Valencia, Valencia, Spain
Valencia, Valencia, Spain
Bilbao, Vizcaya, Spain
Zaragoza, Zaragoza, Spain
Countries
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Other Identifiers
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ML20777
Identifier Type: -
Identifier Source: org_study_id
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