A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer.
Open Label, Phase II Study of Capecitabine (Xeloda®) as Fluoropyrimidine of Choice in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer Suitable for Treatment With a Fluoropyrimidine-Based Regimen
1 other identifier
interventional
158
1 country
51
Brief Summary
This study will assess the safety and efficacy of Xeloda, given in combination with standard chemotherapy regimens, for the first-line treatment of advanced and/or metastatic gastric cancer. All patients will receive Xeloda in combination with one of 4 standard chemotherapy regimens; the dose of Xeloda will be from 625mg/m2 - 1000mg/m2 bid orally, depending on the chemotherapy regimen used. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 gastric-cancer
Started Mar 2007
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 30, 2007
CompletedFirst Posted
Study publicly available on registry
April 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
August 19, 2016
CompletedSeptember 29, 2016
August 1, 2016
3.3 years
March 30, 2007
July 12, 2016
August 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS)
Approximately 3.25 years
Secondary Outcomes (5)
Overall Response Rate (ORR)
Approximately 3.25 years
Progression-Free Survival (PFS)
Approximately 3.25 years
Overall Survival (OS)
Approximately 3.25 years
Duration of Response
Approximately 3.25 years
Time to Response
Approximately 3.25 years
Study Arms (4)
Cisplatin / Capecitabine
EXPERIMENTALCisplatin, 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.
Epirubicin / Cisplatin / Capecitabine
EXPERIMENTALEpirubicin, 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 / Oxaliplatin / Capecitabine
EXPERIMENTALEpirubicin, 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.
Docetaxel / Cisplatin / Capecitabine
EXPERIMENTALDocetaxel, 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.
Interventions
1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle
50 mg/m2/day, IV, every 3 weeks
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age;
- advanced or metastatic gastric cancer;
- Eastern Cooperative Oncology Group (ECOG) \<=2.
You may not qualify if:
- previous chemotherapy (except adjuvant or neoadjuvant treatment \>=6 months prior to study);
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Unknown Facility
Alcoy, Alicante, 03804, Spain
Unknown Facility
Ávila, Avila, 05071, Spain
Unknown Facility
Palma de Mallorca, Balearic Islands, 07014, Spain
Unknown Facility
Palma de Mallorca, Balearic Islands, 07198, Spain
Unknown Facility
Barcelona, Barcelona, 08916, Spain
Unknown Facility
Burgos, Burgos, 09006, Spain
Unknown Facility
Cadiz, Cadiz, 11009, Spain
Unknown Facility
Jerez de la Frontera, Cadiz, 11407, Spain
Unknown Facility
Puerto Real, Cadiz, 11510, Spain
Unknown Facility
Castellon, Castellon, 12002, Spain
Unknown Facility
Córdoba, Cordoba, 14004, Spain
Unknown Facility
Girona, Girona, 17007, Spain
Unknown Facility
Granada, Granada, 18003, Spain
Unknown Facility
Granada, Granada, 18014, Spain
Unknown Facility
Guadalajara, Guadalajara, 19002, Spain
Unknown Facility
Donostia / San Sebastian, Guipuzcoa, 20080, Spain
Unknown Facility
Barbastro, Huesca, 22300, Spain
Unknown Facility
Huesca, Huesca, 22004, Spain
Unknown Facility
Jaén, Jaen, 23007, Spain
Unknown Facility
A Coruña, La Coruña, 15006, Spain
Unknown Facility
A Coruña, La Coruña, 15009, Spain
Unknown Facility
Ferrol, La Coruña, 15405, Spain
Unknown Facility
Santiago de Compostela, La Coruña, 15706, Spain
Unknown Facility
Logroño, La Rioja, 26006, Spain
Unknown Facility
León, Leon, 24071, Spain
Unknown Facility
Lleida, Lerida, 25198, Spain
Unknown Facility
Lugo, Lugo, 27004, Spain
Unknown Facility
Alcorcón, Madrid, 28922, Spain
Unknown Facility
Madrid, Madrid, 28033, Spain
Unknown Facility
Madrid, Madrid, 28034, Spain
Unknown Facility
Madrid, Madrid, 28041, Spain
Unknown Facility
Madrid, Madrid, 28050, Spain
Unknown Facility
Madrid, Madrid, 28222, Spain
Unknown Facility
Madrid, Madrid, 28223, Spain
Unknown Facility
Madrid, Madrid, 28935, Spain
Unknown Facility
Murcia, Murcia, 30008, Spain
Unknown Facility
Navarra, Navarre, 31008, Spain
Unknown Facility
Pamplona, Navarre, 31008, Spain
Unknown Facility
Ourense, Orense, 32005, Spain
Unknown Facility
Palencia, Palencia, 34005, Spain
Unknown Facility
Pontevedra, Pontevedra, 36002, Spain
Unknown Facility
Vigo, Pontevedra, 36312, Spain
Unknown Facility
Gijón, Principality of Asturias, 33394, Spain
Unknown Facility
Salamanca, Salamanca, 37007, Spain
Unknown Facility
Seville, Sevilla, 41013, Spain
Unknown Facility
San Cristóbal de La Laguna, Tenerife, 38320, Spain
Unknown Facility
Toledo, Toledo, 45004, Spain
Unknown Facility
Valencia, Valencia, 41014, Spain
Unknown Facility
Valencia, Valencia, 46026, Spain
Unknown Facility
Bilbao, Vizcaya, 48013, Spain
Unknown Facility
Zaragoza, Zaragoza, 50009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2007
First Posted
April 2, 2007
Study Start
March 1, 2007
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
September 29, 2016
Results First Posted
August 19, 2016
Record last verified: 2016-08