Phase 2
Completed N=435
A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer
Source: ClinicalTrials.gov NCT00118755 ↗Enrolled (actual)
435
Serious AEs
42.5%
Results posted
Mar 2011
Primary outcomePrimary: Progression-free Survival (PFS) — 287; 273 Days — p=0.3883
Summary
This 2-arm study evaluated the efficacy and safety of 2 different treatment schedules of oral Xeloda with intravenous (IV) Eloxatin (oxaliplatin) and IV bevacizumab (Avastin) as a first-line treatment in patients with locally advanced or metastatic colorectal cancer. Patients were randomized to receive either: 1) Xeloda 850 mg/m^2 orally twice a day (po bid) on Days 1-14, oxaliplatin 130 mg/m^2 IV on Day 1, and Avastin 7.5 mg/kg IV on Day 1 of each 3-week cycle; or 2) Xeloda 1500 mg/m^2 po bid on Days 1-7, oxaliplatin 85 mg/m^2 IV on Day 1 and Avastin 5 mg/kg IV on Day 1 of each 2-week cycle. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) |
287; 273 | 0.3883 |
| SECONDARY Overall Survival |
852; 662 | 0.2458 |
| SECONDARY Best Overall Clinical Response |
145; 167; 72; 51; 2; 3 | — |
| SECONDARY Duration of Overall Clinical Response (CR or PR) |
281; 316 | 0.6294 |
Eligibility Criteria
Inclusion Criteria
- Metastatic or inoperable locally advanced colorectal cancer
- >=1 measurable target lesion
Exclusion Criteria
- Previous systemic therapy for advanced or metastatic disease
- Previous treatment with bevacizumab
Data sourced from ClinicalTrials.gov (NCT00118755). 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.