Trial information
A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.
Status: Recruiting
Protocol number: ML18147
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized open-label study phase III Intergroup study: Effect of adding Bevacizumab to crossover fluoropyrimidine based chemotherapy (CTx) in patients with metastatic colorectal cancer and disease progression under first-line standard CTx/Bevacizumab combination.
Brief summary: This study will evaluate the efficacy and safety of adding Avastin to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus Avastin. Patients will be randomized to one of 2 chemotherapy strata. Those in stratum 1 will receive chemotherapy (AIO-IRI, FOLFIRI, CAPIRI or XELIRI) alone, or in combination with Avastin (5mg/kg iv on days 1 and 14 of each 4 week cycle or 7.5mg/kg on days 1 and 22 of each 6 week cycle) and those in stratum 2 will receive chemotherapy (FUFOX, FOLFOX, CAPOX or XELOX) alone, or in combination with Avastin (5mg/kg on days 1 and 14 of each 4 week cycle or 7.5mg/kg on days 1 and 22 of each 6 week cycle). The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals. Target sample size is 820.
Study phase: III
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 Time frame: Event driven
Key secondary outcomes: 1. Overall survival; response rate. Time frame: Event driven
2. AEs, laboratory parameters. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- metastatic colorectal cancer and disease progression, previously treated with first-line chemotherapy plus Avastin;
- ECOG <=2.
Exclusion criteria:
- first line patients with progression-free survival in first line of <4 months;
- other malignancies, except for curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix;
- clinically significant cardiovascular disease within 1 year of randomization;
- CNS metastases.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: September, 2005
Trial registration date: 06/16/2008
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Austria
- Bludesch
- Dornbirn
- Graz
- Hall In Tirol
- Innsbruck
- Knittelfeld
- Leoben
- Linz
- Ried-Innkreis
- Salzburg
- St Pölten
- St Veit an der Glan
- Villach
- Waidhofen A D Thaya
- Wien
France
Germany
- Aachen
- Aschaffenburg
- Augsburg
- Berlin
- Bietigheim-Bissingen
- Bochum
- Bonn
- Bremen
- Darmstadt
- Dessau
- Dortmund
- Dresden
- Duisburg
- Eschweiler
- Essen
- Esslingen
- Frankfurt Am Main
- Fulda
- Gifhorn
- Hamburg
- Hannover
- Hildesheim
- Hof
- Homburg
- Kiel
- Köln
- Köthen (Anhalt)
- Kronach
- Laatzen
- Leer
- Lemgo
- Limburg
- Ludwigsburg
- Magdeburg
- Mainz
- Marburg
- Mönchengladbach
- Mörs
- Mülheim
- München
- Mutlangen
- Neustadt
- Nordhausen
- Regensburg
- Remscheid
- Rostock
- Rotenburg-Wuemme
- Sachsen
- Schönebeck
- Schweinfurt
- Schwerin
- Stade
- Stuttgart
- Troisdorf
- Ulm
- Velbert
- Weiden
- Wernigerode
- Wiesbaden
- Würselen
Norway
