Phase 3
Completed N=123
A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) as Maintenance Treatment in Patients With Metastatic Colorectal Cancer
Source: ClinicalTrials.gov NCT00623805 ↗Enrolled (actual)
123
Serious AEs
26.8%
Results posted
Aug 2014
Primary outcomePrimary: Progression-free Survival — 9.0; 12.6 Months
Summary
This 2 arm study assessed the efficacy and safety of maintenance treatment with Avastin (bevacizumab) + Xeloda (capecitabine), after initial treatment with Xeloda + oxaliplatin + Avastin, in patients with metastatic colorectal cancer. Patients were randomized into one of 2 groups to receive 1) Xeloda + oxaliplatin + Avastin until disease progression or 2) Xeloda + oxaliplatin + Avastin for 6 3-week cycles, followed by Xeloda + Avastin until disease progression. Xeloda was administered at a dose of 1000 mg/m^2 orally twice a day on days 1-14 of each cycle, oxaliplatin at a dose of 130 mg/m^2 intravenously (iv) on day 1 of each cycle, and Avastin at a dose of 7.5 mg/kg iv on day 1 of each cycle.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
9.0; 12.6 | — |
| SECONDARY Overall Survival |
21.0; 25.4 | — |
| SECONDARY Percentage of Participants With a Complete Response or a Partial Response |
53.2; 59.0 | — |
| SECONDARY Time Until a Complete Response or a Partial Response |
3.5; 2.9 | — |
| SECONDARY Duration of Response |
— | — |
| SECONDARY Percentage of Participants With Metastatic Lesions Previously Considered Inoperable Who Became Operable and Underwent Surgery |
58.1; 54.1 | — |
| SECONDARY Percentage of Participants With a R0 Resection |
— | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, ≥ 18 years of age.
- Histologically confirmed colon or rectal cancer, with unresectable metastatic disease.
- At least 1 measurable lesion.
- Outpatient, with Eastern Cooperative Oncology Group (ECOG) Performance Status = 0-1.
Exclusion Criteria
- Previous treatment with Avastin.
- Previous systemic treatment for advanced or metastatic disease.
- clinically significant cardiovascular disease.
- Daily chronic treatment with high doses of aspirin (> 325 mg/day) or non-steroidal anti-inflammatory drugs.
Data sourced from ClinicalTrials.gov (NCT00623805). 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.