Trial information
A Study of Avastin (Bevacizumab) in Combination With Xelox and Tarceva in Patients With Metastatic Colorectal Cancer.
Status: No longer recruiting
Protocol number: ML19875
Sponsor: Roche Farma SA
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the effect of first-line treatment with Avastin+Xelox, followed by Avastin+Tarceva, on progression-free survival in patients with metastatic colorectal cancer
Brief summary: This study will evaluate the efficacy and safety of a first-line regimen of Avastin and Xelox (Xeloda + Eloxatin) followed by Avastin and Tarceva, in patients with metastatic colorectal cancer. Patients will receive 6 x 21 day cycles of treatment with Avastin (7.5mg/kg iv on day 1), Xeloda (1000mg/m2 po twice daily on days 1 to 14) and Eloxatin (130mg/m2 iv on day 1). Patients free of disease progression will then continue with Avastin (7.5mg/kg iv once every 3 weeks) and Tarceva (150mg po daily). The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals. Target sample size is 88.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: Colorectal Cancer
Intervention type: Drug
Intervention name: bevacizumab[Avastin]
Primary outcome: 1. Progression-free survival
Key secondary outcomes: 1. Efficacy: Overall response rate, and overall survival. Safety: adverse events and laboratory tests.
Inclusion criteria:
- adult patients, >=18 years of age;
- adenocarcinoma of colon or rectum, with metastatic disease;
- >=1 measurable lesion.
Exclusion criteria:
- previous treatment with Avastin or Tarceva;
- previous systemic treatment for advanced or metastatic disease;
- adjuvant treatment for non-metastatic disease in past 6 months.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: November, 2006
Trial registration date: 08/16/2006
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Spain
- Burgos
- Huesca
- Jaen
- Lleida
- Logroño
- Palma de Mallorca
- Sabadell
- Santander
- Terrassa
- Teruel
- Vizcaya
- Zaragoza
