Optimized Chemotherapy Followed by Maintenance With Bevacizumab With or Without Erlotinib in Treating Patients With Metastatic Colorectal Cancer That Cannot be Removed by Surgery (DREAM)
NCT ID: NCT00265824
Last Updated: 2015-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
700 participants
INTERVENTIONAL
2005-05-31
Brief Summary
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Detailed Description
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Primary
* Compare Progression-free survival during maintenance period ("Maintenance PFS")in patients with unresectable metastatic colorectal cancer.
Secondary
* Compare the duration of disease control and overall survival of patients treated with these regimens.
* Compare the tolerability of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
* Compare the occurrence of secondary surgery in patients treated with these regimens.
* Compare the chemotherapy-free intervals and response rates in patients treated with these regimens.
INDUCTION THERAPY
Bevacizumab IV over 30-90 minutes on day 1, combined with either:
* modified FOLFOX7 (IV : oxaliplatin, folinic acid, fluorouracil),
* XELOX2 (IV : oxaliplatin, oral capecitabine day 1 to 8),
* FOLFIRI (IV : irinotecan, folinic acid, fluorouracil).
Treatment repeats every 2 weeks.
RANDOMIZATION Patients with stable or responding disease then receive maintenance therapy with bevacizumab alone or bevacizumab+erlotinib
MAINTENANCE THERAPY
* Arm A : bevacizumab alone : bevacizumab IV over 30-90 minutes on day 1
* Arm B : bevacizumab+erlotinib : bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib once daily on days 1-21.
In both arms, treatment with bevacizumab +/- erlotinib repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
ACCRUAL: A total of 700 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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bevacizumab alone
bevacizumab
bevacizumab 7.5mg/kg every 3 weeks until disease progression or limiting toxicity
Bevacizumab + erlotinib
bevacizumab, erlotinib
bevacizumab 7.5mg/kg and oral erlotinib 150 mg/day continuously Cycles every 3 weeks until disease progression or limiting toxicity
Interventions
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bevacizumab
bevacizumab 7.5mg/kg every 3 weeks until disease progression or limiting toxicity
bevacizumab, erlotinib
bevacizumab 7.5mg/kg and oral erlotinib 150 mg/day continuously Cycles every 3 weeks until disease progression or limiting toxicity
Eligibility Criteria
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Inclusion Criteria
* Histologically proven metastatic adenocarcinoma of colon or rectum
* Documented inoperable disease (i.e., not suitable for complete carcinological surgical resection)
* Measurable lesion as assessed by CT scan or MRI in at least one dimension (longest diameter to be recorded) ≥ 20 mm with conventional CT scan or ≥ 10 mm with spiral CT scan
* No previous therapy for metastatic disease
* No history or evidence upon physical examination of CNS disease (e.g., non-irradiated CNS metastasis, seizure not controlled with standard medical therapy, or history of stroke) unless adequately treated
* No exclusive bone metastasis
* ECOG performance status 0-2
* WBC ≥ 1,500/mm\^3
* Platelets ≥ 100,000/mm\^3
* Hemoglobin \> 9 g/dL (may be transfused to maintain or exceed this level)
* Proteinuria \< 2+ by dipstick OR ≤ 1 g of protein on 24-hr urine collection
* Bilirubin \< 1.5 times ULN
* Alkaline phosphatase \< 3 times ULN
* No peripheral sensory neuropathy
* Negative pregnancy test
* Fertile patients must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly, or surgically sterilization)
* No peripheral neuropathy ≥ grade 1
* No clinically significant (i.e. active) cardiovascular disease
* No evidence of bleeding diathesis or coagulopathy
* No serious, non-healing wound, ulcer, or bone fracture
* No significant ophthalmologic abnormality
* More than 28 days since prior major surgical procedure or open biopsy
18 Years
80 Years
ALL
No
Sponsors
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GERCOR - Multidisciplinary Oncology Cooperative Group
OTHER
Responsible Party
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Principal Investigators
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Aimery de Gramont, MD
Role: STUDY_CHAIR
Hopital Saint Antoine
Christophe Tournigand, MD
Role: STUDY_CHAIR
Hopital Henri Mondor
Locations
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LKH Leoben
Leoben, , Austria
LKH Steyr
Steyr, , Austria
AKH Universitätsklinik für Innere Medizin I
Vienna, , Austria
Klinikum Wels-Grieskirchen GmbH
Wels, , Austria
Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada
Cité de la Santé de Laval
Laval, Quebec, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
CHUM Hôpital Notre-Dame
Montreal, Quebec, Canada
Mc Gill University Hospital
Montreal, Quebec, Canada
Hôpital Charles LeMoyne
Montreal, Quebec, Canada
Centre Hospitalier
Antibes, , France
Centre Hospitalier
Auxerre, , France
Centre Hospitalier
Beauvais, , France
Hôpital Avicenne
Bobigny, , France
Polyclinique Bordeaux Nord
Bordeaux, , France
Centre Hospitalier
Briey, , France
Hôpital Pasteur
Colmar, , France
Centre Hospitalier
Dax, , France
Hopital Drevon
Dijon, , France
CHD les oudairies
La Roche-sur-Yon, , France
Clinique Victor Hugo
Le Mans, , France
Hopital Robert Boulin
Libourne, , France
CHU Dupuytren
Limoges, , France
Centre Hospitalier Saint Joseph Saint Luc
Lyon, , France
Hôpital Privé Jean Mermoz
Lyon, , France
Clinique de la sauvegarde
Lyon, , France
hôpital Ambroise Paré
Marseille, , France
Institu Paoli Calmette
Marseille, , France
Centre Hospitalier
Meaux, , France
Clinique Claude BERNARD
Metz, , France
Centre hospitalier Layné
Mont-de-Marsan, , France
Centre Hospitalier Intercommunal Le Raincy - Montfermeil
Montfermeil, , France
centre oncologie de Gentilly
Nancy, , France
Centre Catherine de Sienne
Nantes, , France
Institut Curie
Paris, , France
Groupe Hospitalier les Diaconnesses
Paris, , France
Hôpital Pitié Salpêtrière
Paris, , France
Hôpital Saint Joseph
Paris, , France
Institut Mutualiste Montsouris
Paris, , France
Hopital Saint Antoine
Paris, , France
Hopital Tenon
Paris, , France
centre Catalan oncologie
Perpignan, , France
Clinique Armoricaine
Saint-Brieuc, , France
Centre Hospitalier
Semur-en-Auxois, , France
C.H. Senlis
Senlis, , France
Hopital Foch
Suresnes, , France
Clinique Générale
Valence, , France
Countries
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References
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Tournigand C, Chibaudel B, Samson B, Scheithauer W, Vernerey D, Mesange P, Lledo G, Viret F, Ramee JF, Tubiana-Mathieu N, Dauba J, Dupuis O, Rinaldi Y, Mabro M, Aucoin N, Latreille J, Bonnetain F, Louvet C, Larsen AK, Andre T, de Gramont A. Bevacizumab with or without erlotinib as maintenance therapy in patients with metastatic colorectal cancer (GERCOR DREAM; OPTIMOX3): a randomised, open-label, phase 3 trial. Lancet Oncol. 2015 Nov;16(15):1493-1505. doi: 10.1016/S1470-2045(15)00216-8. Epub 2015 Oct 22.
Other Identifiers
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GERCOR-C04-2
Identifier Type: -
Identifier Source: secondary_id
EU-20565
Identifier Type: -
Identifier Source: secondary_id
GERCOR-OPTIMOX3
Identifier Type: -
Identifier Source: secondary_id
GERCOR-DREAM- C04-2
Identifier Type: -
Identifier Source: secondary_id
CDR0000453861
Identifier Type: -
Identifier Source: org_study_id