A Study of Bevacizumab (Avastin) Versus Placebo in Combination With Capecitabine (Xeloda) and Cisplatin as First-Line Therapy for Advanced Gastric Cancer
NCT ID: NCT00887822
Last Updated: 2017-03-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
202 participants
INTERVENTIONAL
2009-03-31
2014-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Bevacizumab in Combination With Capecitabine and Cisplatin as First-line Therapy in Patients With Advanced Gastric Cancer
NCT00548548
Irinotecan, Cisplatin, and Bevacizumab in Treating Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
NCT00084604
Ph II of Capecitabine, Carboplatin & Bevacizumab for Gastroesophageal Junction & Gastric Carcinoma
NCT00780494
Efficacy and Safety Evaluation of Sintilimab or Placebo in Combination With XELOX as First Line Treatment in Patients With Gastric Cancer
NCT03745170
Oxaliplatin, Capecitabine and Avastin for Metastatic Esophagogastric Adenocarcinoma
NCT00447330
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Bevacizumab, Capecitabine and Cisplatin
Participants will receive bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 milligrams per square meter (mg/m\^2) orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
Bevacizumab
7.5 mg/kg IV infusion on Day 1 of every 3-week cycle
Capecitabine
1000 mg/m\^2 orally twice daily on Days 1-14 of every 3-week cycle
Cisplatin
80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles
Placebo, Capecitabine and Cisplatin
Participants will receive placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
Placebo
Placebo matched to bevacizumab on Day 1 of every 3-week cycle
Capecitabine
1000 mg/m\^2 orally twice daily on Days 1-14 of every 3-week cycle
Cisplatin
80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bevacizumab
7.5 mg/kg IV infusion on Day 1 of every 3-week cycle
Placebo
Placebo matched to bevacizumab on Day 1 of every 3-week cycle
Capecitabine
1000 mg/m\^2 orally twice daily on Days 1-14 of every 3-week cycle
Cisplatin
80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
* Measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Exclusion Criteria
* Previous platinum or anti-angiogenic therapy
* Radiotherapy within 28 days of randomization
* Evidence of Central Nervous System (CNS) metastasis at baseline
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Chongqing, , China
Guangzhou, , China
Hangzhou, , China
Nanjing, , China
Nanjing, , China
Shanghai, , China
Shanghai, , China
Shantou, , China
Shenyang, , China
Wuhan, , China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ML22367
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.