Trial information
A Study of Avastin (Bevacizumab) in Combination Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum
Status: No longer recruiting
Protocol number: ML18524
Sponsor: Roche S.p.A. Italy
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study comparing the effect of 3 chemotherapy regimens containing Avastin on time to disease progression in patients with metastatic colorectal cancer
Brief summary: A study of Avastin (bevacizumab) in combination chemotherapy in patients with metastatic cancer of the colon or rectum. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Target sample size is 300.
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. Time to progression.
Key secondary outcomes: 1. Efficacy: Complete response, partial response, stable disease, progressive disease, overall survival. Safety: Adverse events, laboratory parameters
Inclusion criteria:
- adult patients >=18 years of age;
- colon or rectal cancer, with metastases;
- >=1 measurable lesion.
Exclusion criteria:
- previous systemic treatment for advanced disease;
- radiotherapy to any site within 4 weeks before study;
- daily aspirin (>325 mg/day), anticoagulants, or other medications known to predispose to gastrointestinal ulceration;
- co-existing malignancies or malignancies diagnosed within last 5 years (except basal cell cancer or cervical cancer in situ).
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: June, 2005
Trial registration date: 10/28/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Italy
- Ancona
- Benevento
- Bologna
- Bolzano
- Brescia
- Busto Arsizio
- Cagliari
- Camposampiero
- Carpi
- Catania
- Cremona
- Este
- Firenze
- Gorgonzola
- Grosseto
- Latina
- Lecco
- Legnago
- Mantova
- Milano
- Montecchio Maggiore
- Napoli
- Negrar
- Palermo
- Paola
- Pavia
- Piacenza
- Pisa
- Prato
- Roma
- Saronno
- Sondrio
- Terni
- Torino
- Treviglio
- Udine
- Varese
