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)

December 10, 2015 updated by: GERCOR - Multidisciplinary Oncology Cooperative Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

700

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Leoben, Austria, 8700
        • LKH Leoben
      • Steyr, Austria, 4400
        • LKH Steyr
      • Wels, Austria, 4600
        • Klinikum Wels-Grieskirchen GmbH
      • Wien, Austria, 1090
        • AKH Universitätsklinik für Innere Medizin I
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, H7M 3L9
        • Ottawa Hospital Regional Cancer Centre
    • Quebec
      • Laval, Quebec, Canada, H7M 3L9
        • Cité de la Santé de Laval
      • Montreal, Quebec, Canada, H2L 4M1
        • CHUM Hopital Notre-Dame
      • Montreal, Quebec, Canada, J4V 2H1
        • Hôpital Charles LeMoyne
      • Montreal, Quebec, Canada, H2W 1S6
        • Mc Gill University Hospital
      • Montréal, Quebec, Canada, H1T 2M4
        • Hopital Maisonneuve-Rosemont
  • France
      • Antibes, France, 06606
        • Centre Hospitalier
      • Auxerre, France, 89011
        • Centre Hospitalier
      • Beauvais, France, 60000
        • Centre Hospitalier
      • Bobigny, France, 93000
        • Hopital Avicenne
      • Bordeaux, France, 33000
        • Polyclinique Bordeaux Nord
      • Briey, France, 54140
        • Centre Hospitalier
      • Colmar, France, 68024
        • Hôpital Pasteur
      • Dax, France, 40100
        • Centre Hospitalier
      • Dijon, France, 21000
        • Hopital Drevon
      • La Roche sur Yon, France, 85000
        • CHD les Oudairies
      • Le Mans, France, F-72000
        • Clinique Victor Hugo
      • Libourne, France, 33500
        • Hôpital Robert Boulin
      • Limoges, France, 87000
        • CHU Dupuytren
      • Lyon, France, 69008
        • Hôpital privé Jean Mermoz
      • Lyon, France, 69009
        • Clinique de la Sauvegarde
      • Lyon, France, 69007
        • Centre Hospitalier Saint Joseph Saint Luc
      • Marseille, France, 13000
        • Hôpital Ambroise Paré
      • Marseille, France, 13000
        • Institu Paoli Calmette
      • Meaux, France, 77100
        • Centre Hospitalier
      • Metz, France, 57070
        • Clinique Claude Bernard
      • Mont de Marsan, France, 40000
        • Centre Hospitalier Layné
      • Montfermeil, France, 93370
        • Centre Hospitalier Intercommunal Le Raincy - Montfermeil
      • Nancy, France, 54100
        • centre oncologie de Gentilly
      • Nantes, France, 44000
        • Centre Catherine de Sienne
      • Paris, France, 75970
        • Hôpital Tenon
      • Paris, France, 75014
        • Hopital Saint Joseph
      • Paris, France, 75014
        • Institut Mutualiste Montsouris
      • Paris, France, 75571
        • Hopital Saint Antoine
      • Paris, France, 75005
        • Institut Curie
      • Paris, France, 75013
        • Hôpital Pitie Salpétrière
      • Paris, France, 75012
        • Groupe Hospitalier les Diaconnesses
      • Perpignan, France, 66000
        • centre Catalan oncologie
      • Saint Brieuc, France, 22000
        • Clinique Armoricaine
      • Semur en Auxois, France, 21140
        • Centre Hospitalier
      • Senlis, France, 60309
        • C.H. Senlis
      • Suresnes, France, 92151
        • Hôpital Foch
      • Valence, France, 26000
        • Clinique Générale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: bevacizumab alone
Drug: bevacizumab
bevacizumab 7.5mg/kg every 3 weeks until disease progression or limiting toxicity
Experimental: Bevacizumab + erlotinib
Drug: bevacizumab, erlotinib
bevacizumab 7.5mg/kg and oral erlotinib 150 mg/day continuously Cycles every 3 weeks until disease progression or limiting toxicity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival during maintenance therapy
Time Frame: Tumor evaluation every 2 months
Tumor evaluation every 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Investigators

  • Study Chair: Aimery de Gramont, MD, Hopital Saint Antoine
  • Study Chair: Christophe Tournigand, MD, Hopital Henri Mondor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

December 14, 2005

First Submitted That Met QC Criteria

December 14, 2005

First Posted (Estimate)

December 15, 2005

Study Record Updates

Last Update Posted (Estimate)

December 11, 2015

Last Update Submitted That Met QC Criteria

December 10, 2015

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000453861
  • GERCOR-C04-2
  • EU-20565
  • GERCOR-OPTIMOX3
  • GERCOR-DREAM- C04-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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