Phase 2
Completed N=50
A Study of Avastin (Bevacizumab) and Oxaliplatin Plus Xeloda (Capecitabine) in Patients With Advanced Colorectal Cancer.
Source: ClinicalTrials.gov NCT01159171 ↗Enrolled (actual)
50
Serious AEs
36.7%
Results posted
Aug 2014
Primary outcomePrimary: Percentage of Participants With Objective Response (OR) — 42.86 percentage of participants — p=0.0047
Summary
This study will assess the efficacy and safety of treatment with the combination Avastin (bevacizumab) 5mg/kg iv every 2 weeks, Xeloda (capecitabine) 1000 mg po b.i.d. on Days 1-14 of every 28-day cycle and oxaliplatin 40mg/m2 iv weekly in patients with inoperable locally advanced or metastatic colorectal cancer. The anticipated time on study treatment is until disease progression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response (OR) |
42.86 | 0.0047 sig |
| PRIMARY Percentage of Participants by Best Overall Response |
4.08; 38.78; 38.78; 8.16 | — |
| SECONDARY Duration of Response - Percentage of Participants With an Event by 24 Months |
57.14 | — |
| SECONDARY Duration of Response |
8.31 | — |
| SECONDARY Duration of Stable Disease - Percentage of Participants With an Event by 24 Months |
52.50 | — |
| SECONDARY Duration of Stable Disease |
10.09 | — |
| SECONDARY Time to Treatment Failure (TTF) - Percentage of Participants With an Event by 24 Months |
81.63 | — |
| SECONDARY Time to Treatment Failure |
7.44 | — |
| SECONDARY Time to Progression (TTP) - Percentage of Participants With an Event by 24 Months |
91.84 | — |
| SECONDARY Time to Progression |
9.61 | — |
| SECONDARY Overall Survival (OS) - Percentage of Participants With an Event by 24 Months |
89.90 | — |
| SECONDARY Overall Survival |
20.23 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients >=18 years of age
- Locally advanced or metastatic colorectal cancer
- No previous treatment with chemotherapy for metastatic disease
- Measurable and/or evaluable lesions
Exclusion Criteria
- Radiotherapy within 4 weeks before study
- Untreated brain metastases or primary brain tumors
- Chronic, daily treatment with high-dose aspirin (>325mg/day)
- Co-existing malignancies, or malignancies diagnosed within the last 5 years, with the exception of basal and squamous cell cancer, or cervical cancer in situ
Data sourced from ClinicalTrials.gov (NCT01159171). 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.