Phase 2
Completed N=45
A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) in Patients With Advanced or Metastatic Liver Cancer
Source: ClinicalTrials.gov NCT02013830 ↗Enrolled (actual)
45
Serious AEs
33.3%
Results posted
Jun 2014
Primary outcomePrimary: Percentage of Participants With Objective Response (OR) — 9.1 percentage of participants
Summary
This study will evaluate the efficacy and safety of oral Xeloda (capecitabine) plus intravenous Avastin (bevacizumab) in patients with advanced or metastatic liver cancer. The anticipated time on study treatment is 3-12 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response (OR) |
9.1 | — |
| SECONDARY Percentage of Participants With Disease Control |
52.3 | — |
| SECONDARY Time to Disease Progression - Percentage of Participants With an Event |
77.8 | — |
| SECONDARY Time to Disease Progression |
2.8 | — |
| SECONDARY Time to Disease Progression - Percentage of Participants Progression-free at 12 Months |
24.0 | — |
| SECONDARY Overall Survival - Percentage of Participants With an Event |
77.8 | — |
| SECONDARY Overall Survival |
5.9 | — |
| SECONDARY Overall Survival - Percentage of Participants Event Free at 12 Months |
27 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients >=18 years of age;
- advanced or metastatic liver cancer;
- >=1 measurable lesion.
Exclusion Criteria
- current radiotherapy, chemotherapy, or other experimental therapies;
- prior cytotoxic chemotherapy;
- major surgery, open biopsy, or traumatic injury within 28 days of study entry;
- history of a malignancy during the last 5 years, other than cutaneous basal cell cancer or in situ cervical cancer.
Data sourced from ClinicalTrials.gov (NCT02013830). 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.