Phase 2
Completed N=60
Oxaliplatin, Capecitabine and Avastin for Metastatic Esophagogastric Adenocarcinoma
Esophageal Cancer · Gastric Cancer · Neoplasm Metastasis
Source: ClinicalTrials.gov NCT00447330 ↗
Enrolled (actual)
60
Serious AEs
56.9%
Results posted
Jan 2015
Primary outcomePrimary: Median Progression-Free Survival (PFS) — 6.97 survival time in months
Summary
The purpose of this study is to evaluate the progression free survival of capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin) in previously untreated metastatic esophagogastric adenocarcinomas.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Progression-Free Survival (PFS) |
6.97 | — |
| SECONDARY To Assess the Safety and Tolerability of the Combination of Bevacizumab, Oxaliplatin and Capecitabine in Patients With Previously Untreated Metastatic Esophagogastric Adenocarcinoma |
56 | — |
| SECONDARY Response Rate |
41.7 | — |
| SECONDARY Median Survival |
10.51 | — |
Eligibility Criteria
Primary Inclusion Criteria:
- Histologically or cytologically documented and radiographically measurable adenocarcinoma of the esophagus or stomach that is metastatic/recurrent and not amenable to potentially curative treatment
- No prior therapy for metastatic disease
- Prior radiation therapy is permitted, provided it is completed > 28 days prior to day 1 of study drug
- Normal organ and marrow function
- Karnofsky Performance Status 70-100%
Primary Exclusion Criteria:
- Unstable or poorly controlled hypertension > 150/100 mm Hg
- Arterial thromboembolic events within 6 months
- Clinically significant uncontrolled cardiac disease
- Significant proteinuria at baseline
- Grade 2 or greater peripheral neuropathy
- History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months
Data sourced from ClinicalTrials.gov (NCT00447330). 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.