A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00700102
First received: June 17, 2008
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

This study will evaluate the efficacy and safety of adding Avastin (bevacizumab) 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 or unacceptable toxicity occurs.


Condition Intervention Phase
Colorectal Cancer
Drug: bevacizumab [Avastin]
Drug: AIO-IRI, FOLFIRI, CAPIRI or XELIRI
Drug: FUFOX, FOLFOX, CAPOX or XELOX
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Phase III Intergroup Study: Effect of Adding Bevacizumab to Cross Over Fluoropyrimidine Based Chemotherapy (CTx) in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line Standard CTx/Bevacizumab Combination

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival (time from randomization to death of any cause) [ Time Frame: approximately 6.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival from time of starting first-line therapy [ Time Frame: approximately 6.5 years ] [ Designated as safety issue: No ]
  • Progression-free survival (after first progression) [ Time Frame: approximately 6.5 years ] [ Designated as safety issue: No ]
  • Response rate, tumor assessments according to RECIST criteria [ Time Frame: approximately 6.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 6.5 years ] [ Designated as safety issue: No ]

Enrollment: 821
Study Start Date: February 2006
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemotherapy 1 + Avastin Drug: bevacizumab [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.
Drug: AIO-IRI, FOLFIRI, CAPIRI or XELIRI
As prescribed
Experimental: Chemotherapy 2 + Avastin Drug: bevacizumab [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.
Drug: FUFOX, FOLFOX, CAPOX or XELOX
As prescribed
Active Comparator: Chemotherapy 1 Drug: AIO-IRI, FOLFIRI, CAPIRI or XELIRI
As prescribed
Active Comparator: Chemotherapy 2 Drug: FUFOX, FOLFOX, CAPOX or XELOX
As prescribed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • Diagnosis of progression of disease more than 3 months after last Avastin administration
  • First-line patients with progression-free survival in first-line of <3 months
  • Patients receiving less than 3 consecutive months of Avastin in first-line therapy
  • Past or current history (within the last 2 years prior to treatment start) of 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 6 months prior to start of study treatment
  • Known CNS disease, except for treated CNS metastases as defined by protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700102

  Hide Study Locations
Locations
Austria
Dornbirn, Austria, 6850
Fürstenfeld, Austria, 8280
Graz, Austria, 8020
Graz, Austria, 8036
Hall in Tirol, Austria, 6060
Innsbruck, Austria, 6020
Krems, Austria, 3500
Leoben, Austria, 8700
Linz, Austria, 4020
Rankweil, Austria, 6830
Ried-innkreis, Austria, 4910
Salzburg, Austria, 5020
St Pölten, Austria, 3100
St Veit An Der Glan, Austria, 9300
Steyr, Austria, 4400
Villach, Austria, 9500
Waidhofen A D Thaya, Austria, 3830
Wels, Austria, 4600
Wien, Austria, 1160
Wiener Neustadt, Austria, 2700
Belgium
Aalst, Belgium, 9300
Assebroek, Belgium, 8310
La Louviere, Belgium, 7100
Leuven, Belgium, 3000
Liege, Belgium, 4000
Turnhout, Belgium, 2300
Czech Republic
Brno, Czech Republic, 656 53
Olomouc, Czech Republic, 775 20
Praha, Czech Republic, 180 81
Praha 5, Czech Republic, 150 06
Denmark
Copenhagen, Denmark, 2100
Esbjerg, Denmark, 6700
Herlev, Denmark, 2730
Herning, Denmark, 7400
Hillerod, Denmark, 3400
Naestved, Denmark, 4700
Estonia
Tallinn, Estonia, 13419
Tallinn, Estonia, 11312
Tartu, Estonia, 51014
Finland
Helsinki, Finland, 00029
Oulu, Finland, 90029
Tampere, Finland, 33520
Turku, Finland, 20520
Vaasa, Finland, 65130
France
Agen, France, 47000
Albi, France, 81030
Amiens, France, 80090
Amilly, France, 45200
Antibes, France, 06600
Antony, France, 92166
Arras, France, 62000
Avignon, France, 84918
Besancon, France, 25030
Beziers, France, 34525
Bordeaux, France, 33077
Bordeaux, France, 33075
Bourgoin Jallieu, France, 38317
Caen, France, 14033
Cahors, France, 46005
Chambray Les Tours, France, 37171
Clermont-ferrand, France, 63003
Colmar, France, 68024
Compiegne, France, 60321
Dechy, France, 59187
Dijon, France, 21079
Grenoble, France, 38000
La Roche Sur Yon, France, 85925
La Seyne Sur Mer, France, 83500
Lagny Sur Marne, France, 77405
Le Kremlin Bicetre, France, 94275
Le Mans, France, 72037
Libourne, France, 33505
Lille, France, 59037
Lille, France, 59020
Limoges, France, 87042
Lliie, France, 59003
Longjumeau, France, 91161
Lyon, France, 69373
Lyon, France, 69337
Lyon, France, 69317
Macon, France, 71000
Marseille, France, 13274
Marseille, France, 13273
Marseille, France, 13285
Meaux, France, 77104
Metz, France, 57038
Mont De Marsan, France, 40024
Montbeliard, France, 25209
Montfermeil, France, 93370
Montpellier, France, 34298
Mougins, France, 6250
Nancy, France, 54100
Nantes, France, 44202
Nantes, France, 44093
Neuilly Sur Seine, France, 92200
Nevers, France, 58033
Nice, France, 06189
Orleans, France, 45100
Paris, France, 75651
Paris, France, 75571
Paris, France, 75877
Paris, France, 75908
Paris, France, 75970
Paris, France, 75674
Perigueux, France, 24000
Pessac, France, 33604
Pierre Benite, France, 69495
Pontoise, France, 95300
Reims, France, 51092
Reims CEDEX, France, 51056
Rennes, France, 35033
Rodez, France, 12027
Rouen, France, 76031
Saint Gregoire, France, 35768
Saint Herblain, France, 44805
Saint Nazaire, France, 44600
Senlis, France, 60309
St Brieuc, France, 22027
St Cloud, France, 92210
Strasbourg, France, 67065
Strasbourg, France, 67098
Strasbourg, France, 67010
Suresnes, France, 92151
Vandoeuvre Les Nancy, France, 54511
Vandoeuvre-les-nancy, France, 54511
Verdun, France, 55107
Germany
Aachen, Germany, 52074
Aachen, Germany, 52064
Aschaffenburg, Germany, 63739
Augsburg, Germany, 86150
Bergisch Gladbach, Germany, 51429
Berlin, Germany, 13585
Berlin, Germany, 14195
Berlin, Germany, 13353
Berlin, Germany, 13125
Berlin, Germany, 10707
Bietigheim-bissingen, Germany, 74321
Bochum, Germany, 44892
Bochum, Germany, 44791
Bonn, Germany, 53113
Bremen, Germany, 28325
Chemnitz, Germany, 09119
Darmstadt, Germany, 64295
Dessau-Roßlau, Germany, 06847
Dortmund, Germany, 44137
Dresden, Germany, 01307
Dresden, Germany, 01127
Duisburg, Germany, 47166
Erlangen, Germany, 97054
Eschweiler, Germany, 52249
Essen, Germany, 45147
Esslingen, Germany, 73730
Flensburg, Germany, 24939
Frankfurt, Germany, 60596
Frechen, Germany, 50226
Fulda, Germany, 36043
Geilenkirchen, Germany, 52511
Gifhorn, Germany, 38518
Greifswald, Germany, 17475
Gummersbach, Germany, 51643
Halle, Germany, 06120
Hamburg, Germany, 22457
Hamburg, Germany, 20249
Hamburg, Germany, 22087
Hamburg, Germany, 22767
Hannover, Germany, 30449
Hannover, Germany, 30625
Heidelberg, Germany, 69120
Heidenheim, Germany, 89522
Hildesheim, Germany, 31135
Hof, Germany, 95028
Homburg/Saar, Germany, 66424
Kassel, Germany, 34131
Kassel, Germany, 34119
Kronach, Germany, 96317
Köln, Germany, 50677
Köln, Germany, 51103
Köln, Germany, 50924
Köthen, Germany, 06366
Laatzen, Germany, 30880
Leer, Germany, 26789
Lehrte, Germany, 31275
Leipzig, Germany, 04289
Lemgo, Germany, 32657
Leverkusen, Germany, 51375
Limburg, Germany, 65549
Ludwigsburg, Germany, 71640
Lübeck, Germany, 23562
Magdeburg, Germany, 39120
Magdeburg, Germany, 39130
Magedburg, Germany, 39104
Mainz, Germany, 55131
Mannheim, Germany, 68165
Marburg, Germany, 35043
Marktredwitz, Germany, 95615
Marl, Germany, 45768
Moers, Germany, 47441
Muenchen, Germany, 81377
Muenster, Germany, 48149
Mutlangen, Germany, 73557
Mönchengladbach, Germany, 41063
Mülheim, Germany, 45468
Neunkirchen/Saar, Germany, 66538
Neustadt, Germany, 01844
Nordhausen, Germany, 99734
Oldenburg, Germany, 26133
Olpe, Germany, 57462
Pinneberg, Germany, 25421
Regensburg, Germany, 93053
Regensburg, Germany, 93049
Remscheid, Germany, 42859
Rostock, Germany, 18107
Rostock, Germany, 18055
Rotenburg, Germany, 27356
Rötha, Germany, 04571
Schwerin, Germany, 19057
Schönebeck, Germany, 39218
Stade, Germany, 21680
Stuttgart, Germany, 70174
Suhl, Germany, 98527
Troisdorf, Germany, 53840
Ulm, Germany, 89081
Velbert, Germany, 42551
Wernigerode, Germany, 38855
Wiesbaden, Germany, 65199
Wuerselen, Germany, 52146
Netherlands
Amersfoort, Netherlands, 3818 ES
Capelle Ad Yssel, Netherlands, 2906 ZC
Leiden, Netherlands, 2334 CK
Tilburg, Netherlands, 5042 AD
Norway
Bergen, Norway, 5021
Kristiansand, Norway, 4604
Lorenskog, Norway, 1478
Oslo, Norway, 0407
Ålesund, Norway, 6026
Portugal
Aveiro, Portugal, 3814-501
Coimbra, Portugal, 3000-075
Lisboa, Portugal, 1495-005
Porto, Portugal, 4200-072
Porto, Portugal, 4200-319
Saudi Arabia
Dammam, Saudi Arabia, 31444
Jeddah, Saudi Arabia, 21589
Jeddah, Saudi Arabia, 21497
Riyadh, Saudi Arabia, 11211
Spain
Elche, Alicante, Spain, 03203
Elda, Alicante, Spain, 03600
Torrevieja, Alicante, Spain, 03186
Oviedo, Asturias, Spain, 33006
Manresa, Barcelona, Spain, 08243
Sabadell, Barcelona, Barcelona, Spain, 08208
Sant Cugat Del Valles, Barcelona, Spain, 28981
Cádiz, Cadiz, Spain, 11009
Santander, Cantabria, Spain, 39008
San Sebastian, Guipuzcoa, Spain, 20080
Palma de Mallorca, Islas Baleares, Spain, 07198
La Coruna, La Coruña, Spain, 15006
Alcorcon, Madrid, Spain, 28922
Parla, Madrid, Spain, 28981
Reus, Tarragona, Spain, 43204
Sagunto, Valencia, Spain, 46520
Bilbao, Vizcaya, Spain, 48013
Alicante, Spain, 3010
Barcelona, Spain, 08916
Barcelona, Spain, 08041
Barcelona, Spain, 08017
Barcelona, Spain, 08906
Barcelona, Spain, 08035
Barcelona, Spain, 08227
Burgos, Spain, 09006
Castellon, Spain, 12002
Cordoba, Spain, 14004
Girona, Spain, 17007
Granada, Spain, 18014
Huelva, Spain, 21005
Lerida, Spain, 25198
Madrid, Spain, 28040
Madrid, Spain, 28034
Madrid, Spain, 28002
Madrid, Spain, 28041
Madrid, Spain, 28943
Murcia, Spain, 30008
Navarra, Spain, 31008
Sevilla, Spain, 41014
Valencia, Spain, 46015
Valencia, Spain, 46026
Valencia, Spain, 46017
Valencia, Spain, 41014
Zaragoza, Spain, 50009
Sweden
Lund, Sweden, 22185
Uppsala, Sweden, 751 85
Vaxjo, Sweden, 35185
Switzerland
Aarau, Switzerland, 5000
Basel, Switzerland, 4031
Bern, Switzerland, 3011
Chur, Switzerland, 7000
Luzern, Switzerland, 6004
Winterthur, Switzerland, 8401
Zürich, Switzerland, 8091
Zürich, Switzerland, 8038
Zürich, Switzerland, 8063
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00700102     History of Changes
Other Study ID Numbers: ML18147
Study First Received: June 17, 2008
Last Updated: May 30, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014