A Study of Bevacizumab (Avastin) Versus Placebo in Combination With Capecitabine (Xeloda) and Cisplatin as First-Line Therapy for Advanced Gastric Cancer
AVATAR
A Double-Blind, Randomized, Multicenter, Phase III Study of Bevacizumab in Combination With Capecitabine and Cisplatin Versus Placebo in Combination With Capecitabine and Cisplatin, as First-Line Therapy in Patients With Advanced Gastric Cancer.
1 other identifier
interventional
202
1 country
14
Brief Summary
This 2 arm study will compare the efficacy and safety of bevacizumab in combination with capecitabine and cisplatin versus placebo in combination with capecitabine and cisplatin in participants who have not received prior chemotherapy for advanced or metastatic gastric cancer. Participants will be randomized to one of two treatment groups Bevacizumab + Capecitabine/Cisplatin (experimental arm) or Placebo + Capecitabine/Cisplatin (control arm).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 gastric-cancer
Started Mar 2009
Typical duration for phase_3 gastric-cancer
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 22, 2009
CompletedFirst Posted
Study publicly available on registry
April 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
March 1, 2017
CompletedMarch 1, 2017
January 1, 2017
2.2 years
April 22, 2009
October 31, 2016
January 10, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Event (Death)
Percentage of participants who died due to any cause was reported. As planned, ad hoc analysis was done for overall survival up to clinical cut-off date of 12 January 2012 (34 months), subsequent to the protocol-defined clinical cut-off date of 13 May 2011 (26 months). Overall survival was defined as the time between randomization and the date of death due to any cause.
From randomization until death (up to 34 months)
Overall Survival
Overall survival was defined as the time between randomization and the date of death due to any cause. Overall survival was estimated using Kaplan Meier method. Reported data included censored observations. Participants for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive. As planned, ad hoc analysis was done for overall survival up to clinical clinical cut-off date of 12 January 2012 (34 months), subsequent to the protocol-defined clinical cut-off date of 13 May 2011 (26 months).
From randomization until death (up to 34 months)
Secondary Outcomes (11)
Percentage of Participants With Progression-Free Survival (PFS) Events (Disease Progression/Death)
From randomization until disease progression or death (up to 26 months)
Progression-Free Survival (PFS)
From randomization until disease progression or death (up to 26 months)
Percentage of Participants With PFS Events (Disease Progression/Death) During First-line Therapy
From randomization until disease progression or death (up to 26 months)
PFS During First-line Therapy
From randomization until disease progression or death (up to 26 months)
Percentage of Participants With Disease Progression
From randomization until disease progression or death (up to 26 months)
- +6 more secondary outcomes
Study Arms (2)
Bevacizumab, Capecitabine and Cisplatin
EXPERIMENTALParticipants 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.
Placebo, Capecitabine and Cisplatin
PLACEBO COMPARATORParticipants 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.
Interventions
7.5 mg/kg IV infusion on Day 1 of every 3-week cycle
Placebo matched to bevacizumab on Day 1 of every 3-week cycle
1000 mg/m\^2 orally twice daily on Days 1-14 of every 3-week cycle
80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles
Eligibility Criteria
You may qualify if:
- Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable, locally advanced or metastatic disease, not amenable to curative therapy
- 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)
You may not qualify if:
- Previous chemotherapy for locally advanced or metastatic gastric cancer
- Previous platinum or anti-angiogenic therapy
- Radiotherapy within 28 days of randomization
- Evidence of Central Nervous System (CNS) metastasis at baseline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Unknown Facility
Beijing, 100021, China
Unknown Facility
Beijing, 100071, China
Unknown Facility
Beijing, 100142, China
Unknown Facility
Beijing, 100853, China
Unknown Facility
Chongqing, 400042, China
Unknown Facility
Guangzhou, 510060, China
Unknown Facility
Hangzhou, 310016, China
Unknown Facility
Nanjing, 210036, China
Unknown Facility
Nanjing, China
Unknown Facility
Shanghai, 200032, China
Unknown Facility
Shanghai, 200080, China
Unknown Facility
Shantou, 515041, China
Unknown Facility
Shenyang, 110001, China
Unknown Facility
Wuhan, 430030, China
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 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2009
First Posted
April 24, 2009
Study Start
March 1, 2009
Primary Completion
May 1, 2011
Study Completion
August 1, 2014
Last Updated
March 1, 2017
Results First Posted
March 1, 2017
Record last verified: 2017-01