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)

NCT00265824 | Completed Phase 3

• 5 other identifiers: CDR0000453861GERCOR-C04-2EU-20565GERCOR-OPTIMOX3GERCOR-DREAM- C04-2
• Study Type: interventional
• Target: 700
• Locations: 3 countries
• Sites: 47

Brief Summary

PURPOSE: This randomized phase III trial is studying maintenance therapy with bevacizumab alone after an induction therapy combining bevacizumab+chemotherapy to see how well they work compared to maintenance therapy with bevacizumab+erlotinib alone after an induction therapy combining bevacizumab+chemotherapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.

Conditions

Colorectal Cancer

Keywords

stage IV colon cancer; stage IV rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival during maintenance therapy

  Tumor evaluation every 2 months

Study Arms (2)

bevacizumab alone

ACTIVE COMPARATOR

Drug: bevacizumab

Bevacizumab + erlotinib

EXPERIMENTAL

Drug: bevacizumab, erlotinib

Interventions

bevacizumab DRUG

bevacizumab 7.5mg/kg every 3 weeks until disease progression or limiting toxicity

bevacizumab alone

bevacizumab, erlotinib DRUG

bevacizumab 7.5mg/kg and oral erlotinib 150 mg/day continuously Cycles every 3 weeks until disease progression or limiting toxicity

Bevacizumab + erlotinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

MAIN ELIGIBILITY 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead

Study Sites (47)

LKH Leoben

Leoben, 8700, Austria

Location

LKH Steyr

Steyr, 4400, Austria

Location

AKH Universitätsklinik für Innere Medizin I

Vienna, 1090, Austria

Location

Klinikum Wels-Grieskirchen GmbH

Wels, 4600, Austria

Location

Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, H7M 3L9, Canada

Location

Cité de la Santé de Laval

Laval, Quebec, H7M 3L9, Canada

Location

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

CHUM Hôpital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

Mc Gill University Hospital

Montreal, Quebec, H2W 1S6, Canada

Location

Hôpital Charles LeMoyne

Montreal, Quebec, J4V 2H1, Canada

Location

Centre Hospitalier

Antibes, 06606, France

Location

Centre Hospitalier

Auxerre, 89011, France

Location

Centre Hospitalier

Beauvais, 60000, France

Location

Hôpital Avicenne

Bobigny, 93000, France

Location

Polyclinique Bordeaux Nord

Bordeaux, 33000, France

Location

Centre Hospitalier

Briey, 54140, France

Location

Hôpital Pasteur

Colmar, 68024, France

Location

Centre Hospitalier

Dax, 40100, France

Location

Hopital Drevon

Dijon, 21000, France

Location

CHD les oudairies

La Roche-sur-Yon, 85000, France

Location

Clinique Victor Hugo

Le Mans, F-72000, France

Location

Hopital Robert Boulin

Libourne, 33500, France

Location

CHU Dupuytren

Limoges, 87000, France

Location

Centre Hospitalier Saint Joseph Saint Luc

Lyon, 69007, France

Location

Hôpital Privé Jean Mermoz

Lyon, 69008, France

Location

Clinique de la sauvegarde

Lyon, 69009, France

Location

hôpital Ambroise Paré

Marseille, 13000, France

Location

Institu Paoli Calmette

Marseille, 13000, France

Location

Centre Hospitalier

Meaux, 77100, France

Location

Clinique Claude BERNARD

Metz, 57070, France

Location

Centre hospitalier Layné

Mont-de-Marsan, 40000, France

Location

Centre Hospitalier Intercommunal Le Raincy - Montfermeil

Montfermeil, 93370, France

Location

centre oncologie de Gentilly

Nancy, 54100, France

Location

Centre Catherine de Sienne

Nantes, 44000, France

Location

Institut Curie

Paris, 75005, France

Location

Groupe Hospitalier les Diaconnesses

Paris, 75012, France

Location

Hôpital Pitié Salpêtrière

Paris, 75013, France

Location

Hôpital Saint Joseph

Paris, 75014, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

Hopital Tenon

Paris, 75970, France

Location

centre Catalan oncologie

Perpignan, 66000, France

Location

Clinique Armoricaine

Saint-Brieuc, 22000, France

Location

Centre Hospitalier

Semur-en-Auxois, 21140, France

Location

C.H. Senlis

Senlis, 60309, France

Location

Hopital Foch

Suresnes, 92151, France

Location

Clinique Générale

Valence, 26000, France

Location

Related Publications (1)

• 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.

  PMID: 26474518 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Bevacizumab; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Aimery de Gramont, MD

  Hopital Saint Antoine

  STUDY CHAIR

• Christophe Tournigand, MD

  Hopital Henri Mondor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2005
• First Posted: December 15, 2005
• Study Start: May 1, 2005
• Primary Completion: March 1, 2012
• Last Updated: December 11, 2015

Record last verified: 2014-03

Locations

CA (6); FR (37); AU (4)