Phase 4
Completed N=205
OBELIX Study: A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Cancer of the Colon or Rectum.
Source: ClinicalTrials.gov NCT00577031 ↗Enrolled (actual)
205
Serious AEs
28.4%
Results posted
Aug 2015
Primary outcomePrimary: Progression-Free Survival (PFS): Percentage of Participants With Progressive Disease or Death — 50.25 percentage of participants
Summary
This single arm study will evaluate the efficacy and safety of a first-line regimen of Avastin and XELOX (oxaliplatin + Xeloda) in patients with metastatic cancer of the colon or rectum. Patients will receive 21-day cycles of treatment, comprising Avastin 7.5mg/kg iv on day 1, oxaliplatin 130mg/m2 iv on day 1, and Xeloda 1000mg/m2 po twice daily on days 1-14, for a maximum of 6 months. Patients with stable disease or complete or partial response may continue on Avastin therapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS): Percentage of Participants With Progressive Disease or Death |
50.25 | — |
| PRIMARY PFS: Time to Event |
9.70 | — |
| SECONDARY Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) Among Participants in the ITT Population Who Had at Least 1 Post-Baseline Assessment |
58.79 | — |
| SECONDARY Percentage of Participants With a CR or PR Among Participants in the ITT Population |
49.24 | — |
| SECONDARY Time to CR or PR Overall Response - Time to Event |
3.93 | — |
| SECONDARY Percentage of Participants With a Best Overall Response of CR or PR During First Line Treatment |
54.64 | — |
| SECONDARY Duration of Overall Response Among Participants Whose Best Response Was CR or PR During First Line Treatment - Time to Event |
8.52 | — |
| SECONDARY Percentage of Participants With a Stable Response During First Line Treatment |
52.63 | — |
| SECONDARY Duration of Stable Response |
10.39 | — |
| SECONDARY Percentage of Participants With Treatment Failure |
82.74 | — |
| SECONDARY Time to Treatment Failure |
6.69 | — |
| SECONDARY Overall Survival: Percentage of Participants That Died Due to Any Cause |
50.76 | — |
| SECONDARY Overall Survival: Time to Event |
23.15 | — |
| SECONDARY Percentage of Participants Undergoing Surgical Intervention With Residual Disease Status Post-surgery |
55.77; 13.46; 3.85; 7.69; 3.85; 7.69 | — |
| SECONDARY Percentage of Participants With Best Overall Response of CR or PR by Kirsten Rat Sarcoma Viral Oncogene Homolog (K-Ras)/V-Raf Murine Sarcoma Viral Oncogene Homolog B (B-Raf) Mutation Status |
88.89; 66.67 | — |
| SECONDARY European Quality of Life 5 Dimension (EQ-5D) Raw-Index Score |
80.24; 74.94; -5.30 | 0.0076 sig |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- locally advanced or metastatic colorectal cancer;
- no previous treatment with chemotherapy for metastatic disease;
- at least one measurable lesion.
Exclusion Criteria
- radiotherapy to any site within 4 weeks before study;
- untreated brain metastases or primary brain tumors;
- clinically significant cardiovascular disease;
- chronic daily treatment with high dose aspirin (>325 mg/day);
- other co-existing malignancies or malignancies diagnosed within last 5 years.
Data sourced from ClinicalTrials.gov (NCT00577031). 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.