Phase 3
Completed N=280
A Study of Bevacizumab (Avastin) in Combination With Capecitabine (Xeloda) in Elderly Patients With Metastatic Colorectal Cancer
Source: ClinicalTrials.gov NCT00484939 ↗Enrolled (actual)
280
Serious AEs
30.4%
Results posted
Jun 2014
Primary outcomePrimary: Progression-free Survival — 9.1; 5.1 Months — p=<0.001
Summary
This 2-arm study assessed the efficacy and safety of bevacizumab (Avastin) in combination with capecitabine (Xeloda), compared with capecitabine alone, in elderly patients with metastatic colorectal cancer. Patients were randomized to receive either bevacizumab (7.5 mg/kg intravenously on Day 1 of each 3-week cycle) in combination with capecitabine (1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle) or capecitabine (1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle) alone.
No notable trends or interactions in laboratory values, electrocardiogram, or vital signs suggesting an effect in either direction for capecitabine/bevacizumab combination therapy or capecitabine monotherapy were observed during the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
9.1; 5.1 | <0.001 sig |
| SECONDARY Best Overall Response (BOR) |
2.9; 1.4; 17.1; 8.6; 54.3; 48.6 | 0.029 sig |
| SECONDARY Duration of Response |
9.7; 9.4 | — |
| SECONDARY Time to Response |
NA; NA | — |
| SECONDARY Overall Survival |
20.7; 17.0 | 0.130 |
| SECONDARY Eastern Cooperative Oncology Group (ECOG) Performance Status |
50.4; 34.5; 47.0; 58.2; 1.7; 5.5 | — |
| SECONDARY Percentage of Participants Requiring Additional Treatment for Malignancy |
50.7; 49.3 | — |
| SECONDARY Duration of Follow-up |
540.5; 479.2 | — |
| SECONDARY AEs, Laboratory Parameters, Vital Signs |
— | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, ≥ 70 years of age.
- Cancer of the colon or rectum.
- Metastatic disease diagnosed ≤ 6 months before enrollment.
- ≥ 1 measurable metastatic lesion.
Exclusion Criteria
- Adjuvant anti-vascular endothelial growth factor (VEGF) treatment.
- Prior chemotherapeutic treatment for metastatic colorectal cancer.
- Past or current history of other malignancies (with the exception of basal and squamous cell cancer of the skin, or in situ cancer of the cervix).
- Clinically significant cardiovascular disease.
- Current or recent daily use of aspirin (> 325 mg/day) or other non-steroidal anti-inflammatory drug (NSAID), or full dose anticoagulants.
Data sourced from ClinicalTrials.gov (NCT00484939). 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.