Trial information
OBELIX Study: A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Cancer of the Colon or Rectum.
Status: Recruiting
Protocol number: ML21380
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: Open-label, efficacy and safety study of bevacizumab (Avastin®) in combination with XELOX (Oxaliplatin plus Xeloda®) for the first-line treatment of patients with Metastatic Cancer of the Colon or Rectum - 'OBELIX'
Brief 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. Target sample size is 200.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Colorectal Cancer
Intervention type: Drug
Intervention name: bevacizumab [Avastin]
Primary outcome: 1. Progression-free survival Time frame: Event driven
Key secondary outcomes: 1. Overall response rate, time to response, duration of response, overall survival rate. Time frame: Event driven
2. AEs, laboratory parameters. Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: February, 2008
Trial registration date: 12/17/2007
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Italy
- Bologna
- Brescia
- Cagliari
- Caserta
- Catanzaro
- Cefalu
- Este
- Fano
- Firenze
- Frattaminore
- Grosseto
- Ivrea
- Lanciano
- Latisana
- Lecce
- Legnago
- Legnano
- Macerata
- Mestre (Ve)
- Napoli
- Negrar
- Orbassano
- Padova
- Palermo
- Pavia
- Piove Di Sacco
- Reggio Calabria
- Reggio Emilia
- Rionero in Vulture
- Roma
- Salerno
- San Giovanni Rotondo
- Sondrio
- Taormina
- Torino
- Venezia
- Verbania
- Zingonia (Bg)
