Phase 2
N=45
A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Colorectal Cancer
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00700570 ↗Enrolled (actual)
45
Serious AEs
24.4%
Results posted
Oct 2015
Primary outcome: Primary: Percentage of Participants With Conversion From Unresectable to Resectable Liver Metastases — 42.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bevacizumab [Avastin] (Drug); capecitabine [Xeloda] (Drug); oxaliplatin (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Conversion From Unresectable to Resectable Liver Metastases |
42.2 | — |
| SECONDARY Percentage of Participants With Disease Progression |
52.6; 46.2 | — |
| SECONDARY Time to Disease Progression |
10.1; 8.7 | 0.1341 |
| SECONDARY Percentage of Participants With a Best Overall Tumor Response of Complete Response (CR) or PR According to RECIST Version 1.1 |
47.4; 34.6 | — |
| SECONDARY Percentage of Participants by Best Overall Tumor Response According to RECIST Version 1.1 |
36.8; 0; 10.5; 34.6; 0; 15.4 | 0.0010 sig |
Summary
This single arm study will assess the resection rate of liver metastasis, time to disease progression, and safety of neoadjuvant treatment with Avastin in combination with oxaliplatin and capecitabine (XELOX) in patients with metastatic colorectal cancer with unresectable liver metastasis. Patients will receive Avastin 5mg/kg iv on day 1 of every 2 week cycle, oxaliplatin 85mg/m2 iv on day 1 of every 2 week cycle, and capecitabine 1000mg/m2 on days 1-5 and 8-12 of every 2 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Eligibility Criteria
Inclusion Criteria
- adult patients, =1 measurable lesion;
- ECOG status 0-2.
Exclusion Criteria
- prior exposure to Avastin;
- clinical or radiological evidence of CNS metastases;
- uncontrolled hypertension, or clinically significant cardiovascular disease;
- ongoing treatment with aspirin (>325mg/day) or other medications known to predispose to gastrointestinal ulceration.
Data sourced from ClinicalTrials.gov (NCT00700570). 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.