Trial information
A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) in Elderly Patients With Metastatic Colorectal Cancer.
Status: Recruiting
Protocol number: MO19286
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study to evaluate the effect of Avastin in combination with Xeloda on progression-free survival in elderly patients with metastatic colorectal cancer
Brief summary: This 2 arm study will assess the efficacy and safety of Avastin in combination with Xeloda, compared with Xeloda alone, in elderly patients with metastatic colorectal cancer. Patients will be randomized to receive either Avastin (7.5mg/kg iv on day 1 of each 3 week cycle), in combination with Xeloda (1000mg/m2 po bid on days 1-14 of each 3 week cycle), or Xeloda (1000mg/m2 po bid on days 1-14 of each 3 week cycle) alone. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is
430.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; 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. Best overall response, duration of response, time to response, overall survival. Time frame: Event driven
2. AEs, laboratory parameters, vital signs. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=70 years of age
- cancer of the colon or rectum;
- metastatic disease diagnosed <=6 months before enrolment;
- >=1 measurable metastatic lesion.
Exclusion criteria:
- adjuvant anti-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 (>325mg/day) or other NSAID, or full dose anticoagulants.
Gender: Males or Females
Age limits: Min: 70 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: July, 2007
Trial registration date: 08/16/2006
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Austria
- Innsbruck
- Linz
- Salzburg
- Wien
Canada
- Calgary, AB
- Vancouver, BC
- Halifax, NS
- Ottawa, ON
- Toronto, ON
- Montreal, QC
Greece
Hungary
- Budapest
- Gyor
- Zalaegerszeg
Italy
- Firenze
- Lecce
- Reggio Emilia
- Roma
Korea, Republic of
Mexico
Netherlands
Poland
Slovenia
Spain
- Jaen
- Las Palmas de Gran Canaria
- Leganes
- Madrid
- Murcia
- Zaragoza
United Kingdom
- Bristol
- Denbigh
- Glasgow
- Leicester
- Manchester
- Nottingham
- Sutton
