search
Back to results

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) (DREAM)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
bevacizumab
bevacizumab, erlotinib
Sponsored by
GERCOR - Multidisciplinary Oncology Cooperative Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, chemotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LKH Leoben
  • LKH Steyr
  • Klinikum Wels-Grieskirchen GmbH
  • AKH Universitätsklinik für Innere Medizin I
  • Ottawa Hospital Regional Cancer Centre
  • Cité de la Santé de Laval
  • CHUM Hôpital Notre-Dame
  • Mc Gill University Hospital
  • Hôpital Charles LeMoyne
  • Hôpital Maisonneuve-Rosemont
  • Centre Hospitalier
  • Centre Hospitalier
  • Centre Hospitalier
  • Hôpital Avicenne
  • Polyclinique Bordeaux Nord
  • Centre Hospitalier
  • Hôpital Pasteur
  • Centre Hospitalier
  • Hopital Drevon
  • CHD les oudairies
  • Clinique Victor Hugo
  • Hopital Robert Boulin
  • CHU Dupuytren
  • Centre Hospitalier Saint Joseph Saint Luc
  • Hôpital Privé Jean Mermoz
  • Clinique de la sauvegarde
  • hôpital Ambroise Paré
  • Institu Paoli Calmette
  • Centre Hospitalier
  • Clinique Claude BERNARD
  • Centre hospitalier Layné
  • Centre Hospitalier Intercommunal Le Raincy - Montfermeil
  • centre oncologie de Gentilly
  • Centre Catherine de Sienne
  • Institut Curie
  • Groupe Hospitalier les Diaconnesses
  • Hôpital Pitié Salpêtrière
  • Hôpital Saint Joseph
  • Institut Mutualiste Montsouris
  • Hopital Saint Antoine
  • Hopital Tenon
  • centre Catalan oncologie
  • Clinique Armoricaine
  • Centre Hospitalier
  • C.H. Senlis
  • Hopital Foch
  • Clinique Générale

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

bevacizumab alone

Bevacizumab + erlotinib

Arm Description

Outcomes

Primary Outcome Measures

Progression-free survival during maintenance therapy

Secondary Outcome Measures

Full Information

First Posted
December 14, 2005
Last Updated
December 10, 2015
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
search

1. Study Identification

Unique Protocol Identification Number
NCT00265824
Brief Title
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)
Acronym
DREAM
Official Title
Phase III Study of an Optimized Chemotherapy Followed by Maintenance With Bevacizumab Strategy With or Without Erlotinib in Unresectable Metastatic Colorectal Cancer. DREAM OPTIMOX 3. C04-2
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bevacizumab alone
Arm Type
Active Comparator
Arm Title
Bevacizumab + erlotinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Intervention Description
bevacizumab 7.5mg/kg every 3 weeks until disease progression or limiting toxicity
Intervention Type
Drug
Intervention Name(s)
bevacizumab, erlotinib
Intervention Description
bevacizumab 7.5mg/kg and oral erlotinib 150 mg/day continuously Cycles every 3 weeks until disease progression or limiting toxicity
Primary Outcome Measure Information:
Title
Progression-free survival during maintenance therapy
Time Frame
Tumor evaluation every 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aimery de Gramont, MD
Organizational Affiliation
Hopital Saint Antoine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Christophe Tournigand, MD
Organizational Affiliation
Hopital Henri Mondor
Official's Role
Study Chair
Facility Information:
Facility Name
LKH Leoben
City
Leoben
ZIP/Postal Code
8700
Country
Austria
Facility Name
LKH Steyr
City
Steyr
ZIP/Postal Code
4400
Country
Austria
Facility Name
Klinikum Wels-Grieskirchen GmbH
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
AKH Universitätsklinik für Innere Medizin I
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Ottawa Hospital Regional Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
H7M 3L9
Country
Canada
Facility Name
Cité de la Santé de Laval
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7M 3L9
Country
Canada
Facility Name
CHUM Hôpital Notre-Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Mc Gill University Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Hôpital Charles LeMoyne
City
Montreal
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Hôpital Maisonneuve-Rosemont
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Centre Hospitalier
City
Antibes
ZIP/Postal Code
06606
Country
France
Facility Name
Centre Hospitalier
City
Auxerre
ZIP/Postal Code
89011
Country
France
Facility Name
Centre Hospitalier
City
Beauvais
ZIP/Postal Code
60000
Country
France
Facility Name
Hôpital Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Polyclinique Bordeaux Nord
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Centre Hospitalier
City
Briey
ZIP/Postal Code
54140
Country
France
Facility Name
Hôpital Pasteur
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Centre Hospitalier
City
Dax
ZIP/Postal Code
40100
Country
France
Facility Name
Hopital Drevon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CHD les oudairies
City
La Roche sur Yon
ZIP/Postal Code
85000
Country
France
Facility Name
Clinique Victor Hugo
City
Le Mans
ZIP/Postal Code
F-72000
Country
France
Facility Name
Hopital Robert Boulin
City
Libourne
ZIP/Postal Code
33500
Country
France
Facility Name
CHU Dupuytren
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
Centre Hospitalier Saint Joseph Saint Luc
City
Lyon
ZIP/Postal Code
69007
Country
France
Facility Name
Hôpital Privé Jean Mermoz
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Clinique de la sauvegarde
City
Lyon
ZIP/Postal Code
69009
Country
France
Facility Name
hôpital Ambroise Paré
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
Institu Paoli Calmette
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
Centre Hospitalier
City
Meaux
ZIP/Postal Code
77100
Country
France
Facility Name
Clinique Claude BERNARD
City
Metz
ZIP/Postal Code
57070
Country
France
Facility Name
Centre hospitalier Layné
City
Mont de Marsan
ZIP/Postal Code
40000
Country
France
Facility Name
Centre Hospitalier Intercommunal Le Raincy - Montfermeil
City
Montfermeil
ZIP/Postal Code
93370
Country
France
Facility Name
centre oncologie de Gentilly
City
Nancy
ZIP/Postal Code
54100
Country
France
Facility Name
Centre Catherine de Sienne
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Groupe Hospitalier les Diaconnesses
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hôpital Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital Saint Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
centre Catalan oncologie
City
Perpignan
ZIP/Postal Code
66000
Country
France
Facility Name
Clinique Armoricaine
City
Saint Brieuc
ZIP/Postal Code
22000
Country
France
Facility Name
Centre Hospitalier
City
Semur en Auxois
ZIP/Postal Code
21140
Country
France
Facility Name
C.H. Senlis
City
Senlis
ZIP/Postal Code
60309
Country
France
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
Clinique Générale
City
Valence
ZIP/Postal Code
26000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26474518
Citation
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. Erratum In: Lancet Oncol. 2015 Dec;16(16):e589.
Results Reference
derived

Learn more about this trial

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)

We'll reach out to this number within 24 hrs