Phase 3 N=202 Randomized Double-blind Treatment

A Study of Bevacizumab (Avastin) Versus Placebo in Combination With Capecitabine (Xeloda) and Cisplatin as First-Line Therapy for Advanced Gastric Cancer

Gastric Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00887822 ↗

Enrolled (actual)

202

Serious AEs

19.9%

Results posted

Mar 2017

Primary outcome: Primary: Percentage of Participants With Event (Death) — 77.0; 75.5 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Bevacizumab (Drug); Placebo (Drug); Capecitabine (Drug); Cisplatin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: May 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Event (Death)	77.0; 75.5	—
PRIMARY Overall Survival	10.5; 11.4	0.8636
SECONDARY Percentage of Participants With Progression-Free Survival (PFS) Events (Disease Progression/Death)	81.0; 81.4	—
SECONDARY Progression-Free Survival (PFS)	6.3; 6.0	0.4709
SECONDARY Percentage of Participants With PFS Events (Disease Progression/Death) During First-line Therapy	51.0; 59.8	—
SECONDARY PFS During First-line Therapy	6.3; 6.1	0.3685
SECONDARY Percentage of Participants With Disease Progression	56.0; 53.9	—
SECONDARY Time to Progression	6.5; 7.0	0.8589
SECONDARY Percentage of Participants With Best Overall Response as Assessed by RECIST During First-Line Therapy	40.7; 33.7	0.3480
SECONDARY Duration of Response During First-Line Therapy	7.2; 5.8	0.0462 sig
SECONDARY Percentage of Participants With Disease Control During First-Line Therapy	73.0; 72.5	0.9426
SECONDARY 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	1.24; 0.73; -0.89; -0.99; -0.65; -0.37	—
SECONDARY Change From Cycle 1 in EORTC QLQ-STO22 Scale Over Time	-0.31; -0.05; -0.97; -0.52; -0.27; -0.43	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00887822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.