Clinical trial NCT00887822: A Study of Bevacizumab (Avastin) Versus Placebo in Combination With Capecitabine (Xeloda) and Cisplatin as First-Line Therapy for Advanced Gastric Cancer
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-04-24
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants With Event (Death)
timeFrame: From randomization until death (up to 34 months)
measure: Overall Survival
timeFrame: From randomization until death (up to 34 months)
Secondary outcomes:
measure: Percentage of Participants With Progression-Free Survival (PFS) Events (Disease Progression/Death)
timeFrame: From randomization until disease progression or death (up to 26 months)
measure: Progression-Free Survival (PFS)
timeFrame: From randomization until disease progression or death (up to 26 months)
measure: Percentage of Participants With PFS Events (Disease Progression/Death) During First-line Therapy
timeFrame: From randomization until disease progression or death (up to 26 months)
measure: PFS During First-line Therapy
timeFrame: From randomization until disease progression or death (up to 26 months)
measure: Percentage of Participants With Disease Progression
timeFrame: From randomization until disease progression or death (up to 26 months)
measure: Time to Progression
timeFrame: From randomization until disease progression or death (up to 26 months)
measure: Percentage of Participants With Best Overall Response as Assessed by RECIST During First-Line Therapy
timeFrame: From randomization until disease progression or death (up to 26 months)
measure: Duration of Response During First-Line Therapy
timeFrame: From randomization until disease progression or death (up to 26 months)
measure: Percentage of Participants With Disease Control During First-Line Therapy
timeFrame: From randomization until disease progression or death (up to 26 months)
measure: Change From Cycle 1 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 36 (QLQ-C30) Scale Over Time
timeFrame: From Cycle 1 until disease progression (up to 26 months)
measure: Change From Cycle 1 in EORTC QLQ-STO22 Scale Over Time
timeFrame: From Cycle 1 until disease progression (up to 26 months)
Other outcomes:
Locations:
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: ChongQing
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Nanjing
country: China
city: Nanjing
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shantou
country: China
city: Shenyang
country: China
city: Wuhan
country: China
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: