Phase 3
Completed N=202
A Study of Bevacizumab (Avastin) Versus Placebo in Combination With Capecitabine (Xeloda) and Cisplatin as First-Line Therapy for Advanced Gastric Cancer
Source: ClinicalTrials.gov NCT00887822 ↗Enrolled (actual)
202
Serious AEs
19.9%
Results posted
Mar 2017
Primary outcomePrimary: Percentage of Participants With Event (Death) — 77.0; 75.5 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
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 | — |
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
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. Informational only — not medical advice.