AzTrials
AzTrials

Colorectal CancerPhase 3NCT00700102

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

A Phase 3 study testing Chemotherapy and Bevacizumab in people with Colorectal Cancer, run by Hoffmann-La Roche at 300 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate the efficacy and safety of adding 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 bevacizumab. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Chemotherapy and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
820 participants
Where
300 sitesin 15 countries
Study dates
Feb 2006to May 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients, >=18 years of age
  • Metastatic colorectal cancer and disease progression
  • Previously treated with first-line chemotherapy plus Avastin
  • Eastern Cooperative Oncology Group (ECOG) performance status <=2.

Who cannot join

  • 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 central nervous system (CNS) disease, except for treated CNS metastases as defined by protocol

Trial locations and contacts

300 sites in 15 countries.

300 sites in 15 countries

Germany100 sites

  • Study site

    Aachen, 52064

  • Study site

    Aachen, 52074

  • Study site

    Aschaffenburg, 63739

  • Study site

    Augsburg, 86150

  • Study site

    Bergisch Gladbach, 51429

  • Study site

    Berlin, 10117

  • Study site

    Berlin, 10707

  • Study site

    Berlin, 13125

  • Study site

    Berlin, 13585

  • Study site

    Berlin, 14195

  • Study site

    Bietigheim, 74321

  • Study site

    Bochum, 44791

  • Study site

    Bochum, 44892

  • Study site

    Bonn, 53113

  • Study site

    Bremen, 28325

  • Study site

    Chemnitz, 09119

  • Study site

    Cologne, 50677

  • Study site

    Cologne, 50924

  • Study site

    Cologne, 51103

  • Study site

    Darmstadt, 64295

  • Study site

    Dessau, 06847

  • Study site

    Dortmund, 44137

  • Study site

    Dresden, 01127

  • Study site

    Dresden, 01307

  • Study site

    Duisburg, 47166

  • Study site

    Erlangen, 97054

  • Study site

    Eschweiler, 52249

  • Study site

    Essen, 45122

  • Study site

    Esslingen am Neckar, 73730

  • Study site

    Flensburg, 24939

  • Study site

    Frankfurt, 60596

  • Study site

    Frechen, 50226

  • Study site

    Fulda, 36043

  • Study site

    Geilenkirchen, 52511

  • Study site

    Gifhorn, 38518

  • Study site

    Greifswald, 17475

  • Study site

    Gummersbach, 51643

  • Study site

    Halle, 06120

  • Study site

    Hamburg, 20249

  • Study site

    Hamburg, 22087

  • Study site

    Hamburg, 22457

  • Study site

    Hamburg, 22767

  • Study site

    Hanover, 30449

  • Study site

    Hanover, 30625

  • Study site

    Heidelberg, 69120

  • Study site

    Heidenheim, 89522

  • Study site

    Hildesheim, 31135

  • Study site

    Hof, 95028

  • Study site

    Homburg/Saar, 66424

  • Study site

    Kassel, 34119

  • Study site

    Kassel, 34131

  • Study site

    Köthen, 06366

  • Study site

    Kronach, 96317

  • Study site

    Laatzen, 30880

  • Study site

    Leer, 26789

  • Study site

    Lehrte, 31275

  • Study site

    Leipzig, 04289

  • Study site

    Lemgo, 32657

  • Study site

    Leverkusen, 51375

  • Study site

    Limburg, 65549

  • Study site

    Lübeck, 23562

  • Study site

    Ludwigsburg, 71640

  • Study site

    Magdeburg, 39120

  • Study site

    Magdeburg, 39130

  • Study site

    Magedburg, 39104

  • Study site

    Mainz, 55131

  • Study site

    Mannheim, 68165

  • Study site

    Marburg, 35043

  • Study site

    Marktredwitz, 95615

  • Study site

    Marl, 45768

  • Study site

    Moers, 47441

  • Study site

    Mönchengladbach, 41063

  • Study site

    Mülheim, 45468

  • Study site

    München, 81377

  • Study site

    Münster, 48149

  • Study site

    Mutlangen, 73557

  • Study site

    Neunkirchen/Saar, 66538

  • Study site

    Neustadt, 01844

  • Study site

    Nordhausen, 99734

  • Study site

    Oldenburg, 26133

  • Study site

    Olpe, 57462

  • Study site

    Pinneberg, 25421

  • Study site

    Regensburg, 93049

  • Study site

    Regensburg, 93053

  • Study site

    Remscheid, 42859

  • Study site

    Rostock, 18055

  • Study site

    Rostock, 18107

  • Study site

    Rotenburg (Wümme), 27356

  • Study site

    Rötha, 04571

  • Study site

    Schönebeck, 39218

  • Study site

    Schwerin, 19057

  • Study site

    Stade, 21680

  • Study site

    Stuttgart, 70174

  • Study site

    Suhl, 98527

  • Study site

    Troisdorf, 53840

  • Study site

    Ulm, 89081

  • Study site

    Velbert, 42551

  • Study site

    Wernigerode, 38855

  • Study site

    Wiesbaden, 65199

  • Study site

    Würselen, 52146

Other trials in Germany

France81 sites

  • Study site

    Agen, 47000

  • Study site

    Albi, 81030

  • Study site

    Amiens, 80090

  • Study site

    Amilly, 45200

  • Study site

    Antibes, 06600

  • Study site

    Antony, 92166

  • Study site

    Arras, 62000

  • Study site

    Avignon, 84918

  • Study site

    Besançon, 25030

  • Study site

    Béziers, 34525

  • Study site

    Bordeaux, 33075

  • Study site

    Bordeaux, 33077

  • Study site

    Bourgoin, 38317

  • Study site

    Caen, 14033

  • Study site

    Cahors, 46005

  • Study site

    Chambray-lès-Tours, 37171

  • Study site

    Clermont-Ferrand, 63003

  • Study site

    Colmar, 68024

  • Study site

    Compiègne, 60321

  • Study site

    Dechy, 59187

  • Study site

    Dijon, 21079

  • Study site

    Grenoble, 38000

  • Study site

    La Roche-sur-Yon, 85925

  • Study site

    La Seyne-sur-Mer, 83500

  • Study site

    Lagny-sur-Marne, 77405

  • Study site

    Le Kremlin-Bicêtre, 94275

  • Study site

    Le Mans, 72037

  • Study site

    Libourne, 33505

  • Study site

    Lille, 59020

  • Study site

    Lille, 59037

  • Study site

    Limoges, 87042

  • Study site

    Lliie, 59003

  • Study site

    Longjumeau, 91161

  • Study site

    Lyon, 69317

  • Study site

    Lyon, 69337

  • Study site

    Lyon, 69373

  • Study site

    Mâcon, 71000

  • Study site

    Marseille, 13273

  • Study site

    Marseille, 13274

  • Study site

    Marseille, 13285

  • Study site

    Meaux, 77104

  • Study site

    Metz, 57038

  • Study site

    Mont-de-Marsan, 40024

  • Study site

    Montbéliard, 25209

  • Study site

    Montfermeil, 93370

  • Study site

    Montpellier, 34298

  • Study site

    Mougins, 6250

  • Study site

    Nancy, 54100

  • Study site

    Nantes, 44093

  • Study site

    Nantes, 44202

  • Study site

    Neuilly-sur-Seine, 92200

  • Study site

    Nevers, 58033

  • Study site

    Nice, 06189

  • Study site

    Orléans, 45100

  • Study site

    Paris, 75571

  • Study site

    Paris, 75651

  • Study site

    Paris, 75674

  • Study site

    Paris, 75877

  • Study site

    Paris, 75908

  • Study site

    Paris, 75970

  • Study site

    Périgueux, 24000

  • Study site

    Pessac, 33604

  • Study site

    Pierre-Bénite, 69495

  • Study site

    Pontoise, 95300

  • Study site

    Reims, 51056

  • Study site

    Reims, 51092

  • Study site

    Rennes, 35033

  • Study site

    Rodez, 12027

  • Study site

    Rouen, 76031

  • Study site

    Saint-Brieuc, 22027

  • Study site

    Saint-Cloud, 92210

  • Study site

    Saint-Grégoire, 35768

  • Study site

    Saint-Herblain, 44805

  • Study site

    Saint-Nazaire, 44600

  • Study site

    Senlis, 60309

  • Study site

    Strasbourg, 67010

  • Study site

    Strasbourg, 67065

  • Study site

    Strasbourg, 67098

  • Study site

    Suresnes, 92151

  • Study site

    Vandœuvre-lès-Nancy, 54511

  • Study site

    Verdun, 55107

Other trials in France

Spain45 sites

  • Study site

    A Coruña, La Coruña, 15006

  • Study site

    Alcorcón, Madrid, 28922

  • Study site

    Alicante, Alicante, 3010

  • Study site

    Barcelona, Barcelona, 08017

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    Barcelona, Barcelona, 08041

  • Study site

    Barcelona, Barcelona, 08227

  • Study site

    Barcelona, Barcelona, 08906

  • Study site

    Barcelona, Barcelona, 08916

  • Study site

    Bilbao, Vizcaya, 48013

  • Study site

    Burgos, Burgos, 09006

  • Study site

    Cadiz, Cadiz, 11009

  • Study site

    Castellon, Castellon, 12002

  • Study site

    Córdoba, Cordoba, 14004

  • Study site

    Donostia / San Sebastian, Guipuzcoa, 20080

  • Study site

    Elche, Alicante, 03203

  • Study site

    Elda, Alicante, 03600

  • Study site

    Girona, Girona, 17007

  • Study site

    Granada, Granada, 18014

  • Study site

    Huelva, Huelva, 21005

  • Study site

    Lleida, Lerida, 25198

  • Study site

    Madrid, Madrid, 28002

  • Study site

    Madrid, Madrid, 28007

  • Study site

    Madrid, Madrid, 28034

  • Study site

    Madrid, Madrid, 28040

  • Study site

    Madrid, Madrid, 28041

  • Study site

    Madrid, Madrid, 28943

  • Study site

    Manresa, Barcelona, 08243

  • Study site

    Murcia, Murcia, 30008

  • Study site

    Navarra, Navarre, 31008

  • Study site

    Oviedo, Principality of Asturias, 33011

  • Study site

    Palma de Mallorca, Balearic Islands, 07198

  • Study site

    Parla, Madrid, 28981

  • Study site

    Reus, Tarragona, 43204

  • Study site

    Sabadell, Barcelona, 08208

  • Study site

    Sagunto, Valencia, 46520

  • Study site

    Sant Cugat del Vallès, Barcelona, 28981

  • Study site

    Santander, Cantabria, 39008

  • Study site

    Seville, Sevilla, 41014

  • Study site

    Torrevieja, Alicante, 03186

  • Study site

    Valencia, Valencia, 41014

  • Study site

    Valencia, Valencia, 46015

  • Study site

    Valencia, Valencia, 46017

  • Study site

    Valencia, Valencia, 46026

  • Study site

    Zaragoza, Zaragoza, 50009

Other trials in Spain

Austria20 sites

  • Study site

    Dornbirn, 6850

  • Study site

    Fürstenfeld, 8280

  • Study site

    Graz, 8020

  • Study site

    Graz, 8036

  • Study site

    Hall in Tirol, 6060

  • Study site

    Innsbruck, 6020

  • Study site

    Krems, 3500

  • Study site

    Leoben, 8700

  • Study site

    Linz, 4020

  • Study site

    Rankweil, 6830

  • Study site

    Ried-innkreis, 4910

  • Study site

    Salzburg, 5020

  • Study site

    Sankt Pölten, 3100

  • Study site

    Sankt Veit an der Glan, 9300

  • Study site

    Steyr, 4400

  • Study site

    Vienna, 1160

  • Study site

    Villach, 9500

  • Study site

    Waidhofen A D Thaya, 3830

  • Study site

    Wels, 4600

  • Study site

    Wiener Neustadt, 2700

Other trials in Austria

Switzerland9 sites

  • Study site

    Aarau, 5000

  • Study site

    Basel, 4031

  • Study site

    Bern, 3011

  • Study site

    Chur, 7000

  • Study site

    Lucerne, 6004

  • Study site

    Winterthur, 8401

  • Study site

    Zurich, 8038

  • Study site

    Zurich, 8063

  • Study site

    Zurich, 8091

Other trials in Switzerland

Belgium6 sites

  • Study site

    Aalst, 9300

  • Study site

    Assebroek, 8310

  • Study site

    La Louvière, 7100

  • Study site

    Leuven, 3000

  • Study site

    Liège, 4000

  • Study site

    Turnhout, 2300

Other trials in Belgium

Denmark6 sites

  • Study site

    Copenhagen, 2100

  • Study site

    Esbjerg, 6700

  • Study site

    Herlev, 2730

  • Study site

    Herning, 7400

  • Study site

    Hillerød, 3400

  • Study site

    Næstved, 4700

Other trials in Denmark

Finland5 sites

  • Study site

    Helsinki, 00029

  • Study site

    Oulu, 90029

  • Study site

    Tampere, 33520

  • Study site

    Turku, 20520

  • Study site

    Vaasa, 65130

Other trials in Finland

Norway5 sites

  • Study site

    Ålesund, 6026

  • Study site

    Bergen, 5021

  • Study site

    Kristiansand, 4604

  • Study site

    Lorenskog, 1478

  • Study site

    Oslo, 0407

Other trials in Norway

Portugal5 sites

  • Study site

    Aveiro, 3814-501

  • Study site

    Coimbra, 3000-075

  • Study site

    Lisbon, 1495-005

  • Study site

    Porto, 4200-072

  • Study site

    Porto, 4200-319

Other trials in Portugal

Czechia4 sites

  • Study site

    Brno, 656 53

  • Study site

    Olomouc, 775 20

  • Study site

    Prague, 150 06

  • Study site

    Prague, 180 81

Other trials in Czechia

Netherlands4 sites

  • Study site

    Amersfoort, 3818 ES

  • Study site

    Capelle aan den IJssel, NL 2900 AR

  • Study site

    Leiden, 2334 CK

  • Study site

    Tilburg, 5042 AD

Other trials in Netherlands

Saudi Arabia4 sites

  • Study site

    Dammam, 31444

  • Study site

    Jeddah, 21497

  • Study site

    Jeddah, 21589

  • Study site

    Riyadh, 11211

Other trials in Saudi Arabia

Estonia3 sites

  • Study site

    Tallinn, 11312

  • Study site

    Tallinn, 13419

  • Study site

    Tartu, 51014

Other trials in Estonia

Sweden3 sites

  • Study site

    Lund, 22185

  • Study site

    Uppsala, 75185

  • Study site

    Vaxjo, 35185

Other trials in Sweden

About this study

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

This study will evaluate the efficacy and safety of adding 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 bevacizumab. Participants will receive chemotherapy alone, or in combination with bevacizumab. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Participants are allowed to continue on bevacizumab, even after stopping chemotherapy.

Being tested
Chemotherapy, Bevacizumab
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChemotherapyDrug

    As prescribed

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle.

Study groups in NCT00700102
Study groupRoleWhat they receive
ChemotherapyActive comparatorChemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
Receives: Drug: Chemotherapy
Chemotherapy + BevacizumabExperimentalChemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
Receives: Drug: Chemotherapy; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival: Time From Randomization to Death From Any Cause

    Measured: within 6.5 years

Secondary outcomes (5)

  1. Overall Survival: Months From Time of First Line Therapy

    Measured: within approximately 9.6 years

  2. Participants With Progression Free Survival Event

    Measured: within 6.5 years

  3. Progression Free Survival: Time to Event

    Measured: within 6.5 years

  4. Response Rate: Percentage of Participants With Best Overall Response, Defined as Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST Criteria

    Measured: within 6.5 years

  5. Response Rate: Participants With Response Status Based on RECIST Criteria

    Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.

    Measured: within 6.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2008 (estimated)
  2. Study startFeb 2006
  3. Primary completionMay 2013
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
820 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00700102
Sponsor's protocol ID
ML18147
Other IDs
2006-004634-32
Status last verified
Jul 2015
First submitted
17 Jun 2008
Last updated
30 Jul 2015

Publications

  • Li Y, Hu M, Zhang Z, Chu M, Xu R, Liu L, Dong W, Yang M, Zhang R. Cost-effectiveness analysis of continuing bevacizumab plus chemotherapy versus chemotherapy alone after first progression of metastatic colorectal cancer. Cancer Med. 2024 Jan;13(1):e6904. doi: 10.1002/cam4.6904. Epub 2024 Jan 8.

    PubMed 38186268

  • Kubicka S, Greil R, Andre T, Bennouna J, Sastre J, Van Cutsem E, von Moos R, Osterlund P, Reyes-Rivera I, Muller T, Makrutzki M, Arnold D; ML18147 study investigators including AIO, GERCOR, FFCD, UNICANCER GI, TTD, BGDO, GEMCAD, and AGMT groups. Bevacizumab plus chemotherapy continued beyond first progression in patients with metastatic colorectal cancer previously treated with bevacizumab plus chemotherapy: ML18147 study KRAS subgroup findings. Ann Oncol. 2013 Sep;24(9):2342-9. doi: 10.1093/annonc/mdt231. Epub 2013 Jul 12.

    PubMed 23852309

  • Bennouna J, Sastre J, Arnold D, Osterlund P, Greil R, Van Cutsem E, von Moos R, Vieitez JM, Bouche O, Borg C, Steffens CC, Alonso-Orduna V, Schlichting C, Reyes-Rivera I, Bendahmane B, Andre T, Kubicka S; ML18147 Study Investigators. Continuation of bevacizumab after first progression in metastatic colorectal cancer (ML18147): a randomised phase 3 trial. Lancet Oncol. 2013 Jan;14(1):29-37. doi: 10.1016/S1470-2045(12)70477-1. Epub 2012 Nov 16.

    PubMed 23168366

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Chemotherapy and Bevacizumab in people with Colorectal Cancer, run by Hoffmann-La Roche at 300 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 300 sites in Germany, France, Spain, Austria, Switzerland and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival: Time From Randomization to Death From Any Cause (time frame: within 6.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00700102, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.

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