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Colorectal CancerPhase 3DREAMNCT00265824

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)

A Phase 3 study testing bevacizumab and bevacizumab, erlotinib in people with Colorectal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 47 sites in 3 countries.

Completed

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

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Colorectal Cancer
What is being tested?
bevacizumab and bevacizumab, erlotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
47 sitesin 3 countries
Study dates
May 2005to Mar 2012
Phase
Phase 3
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

47 sites in 3 countries.

47 sites in 3 countries

France37 sites

  • Centre Hospitalier

    Antibes, 06606

  • Centre Hospitalier

    Auxerre, 89011

  • Centre Hospitalier

    Beauvais, 60000

  • Hôpital Avicenne

    Bobigny, 93000

  • Polyclinique Bordeaux Nord

    Bordeaux, 33000

  • Centre Hospitalier

    Briey, 54140

  • Hôpital Pasteur

    Colmar, 68024

  • Centre Hospitalier

    Dax, 40100

  • Hopital Drevon

    Dijon, 21000

  • CHD les oudairies

    La Roche-sur-Yon, 85000

  • Clinique Victor Hugo

    Le Mans, F-72000

  • Hopital Robert Boulin

    Libourne, 33500

  • CHU Dupuytren

    Limoges, 87000

  • Centre Hospitalier Saint Joseph Saint Luc

    Lyon, 69007

  • Hôpital Privé Jean Mermoz

    Lyon, 69008

  • Clinique de la sauvegarde

    Lyon, 69009

  • hôpital Ambroise Paré

    Marseille, 13000

  • Institu Paoli Calmette

    Marseille, 13000

  • Centre Hospitalier

    Meaux, 77100

  • Clinique Claude BERNARD

    Metz, 57070

  • Centre hospitalier Layné

    Mont-de-Marsan, 40000

  • Centre Hospitalier Intercommunal Le Raincy - Montfermeil

    Montfermeil, 93370

  • centre oncologie de Gentilly

    Nancy, 54100

  • Centre Catherine de Sienne

    Nantes, 44000

  • Institut Curie

    Paris, 75005

  • Groupe Hospitalier les Diaconnesses

    Paris, 75012

  • Hôpital Pitié Salpêtrière

    Paris, 75013

  • Hôpital Saint Joseph

    Paris, 75014

  • Institut Mutualiste Montsouris

    Paris, 75014

  • Hopital Saint Antoine

    Paris, 75571

  • Hopital Tenon

    Paris, 75970

  • centre Catalan oncologie

    Perpignan, 66000

  • Clinique Armoricaine

    Saint-Brieuc, 22000

  • Centre Hospitalier

    Semur-en-Auxois, 21140

  • C.H. Senlis

    Senlis, 60309

  • Hopital Foch

    Suresnes, 92151

  • Clinique Générale

    Valence, 26000

Other trials in France

Canada6 sites

  • Cité de la Santé de Laval

    Laval, Quebec, H7M 3L9

  • Hôpital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • CHUM Hôpital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • Mc Gill University Hospital

    Montreal, Quebec, H2W 1S6

  • Hôpital Charles LeMoyne

    Montreal, Quebec, J4V 2H1

  • Ottawa Hospital Regional Cancer Centre

    Ottawa, Ontario, H7M 3L9

Other trials in Canada

Austria4 sites

  • LKH Leoben

    Leoben, 8700

  • LKH Steyr

    Steyr, 4400

  • AKH Universitätsklinik für Innere Medizin I

    Vienna, 1090

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

About this study

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

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.

Read the 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.

Being tested
bevacizumab, bevacizumab, erlotinib
Keywords
stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, chemotherapy
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

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

  • bevacizumabDrug

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

  • bevacizumab, erlotinibDrug

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

Study groups in NCT00265824
Study groupRoleWhat they receive
bevacizumab aloneActive comparatorNot described
Receives: Drug: bevacizumab
Bevacizumab + erlotinibExperimentalNot described
Receives: Drug: bevacizumab, erlotinib

What is being measured

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

  1. Progression-free survival during maintenance therapy

    Measured: Tumor evaluation every 2 months

Timeline

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

  1. First posted15 Dec 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionMar 2012

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
700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00265824
Sponsor's protocol ID
CDR0000453861
Other IDs
GERCOR-C04-2, EU-20565, GERCOR-OPTIMOX3, GERCOR-DREAM- C04-2
Acronym
DREAM
Status last verified
Mar 2014
First submitted
14 Dec 2005
Last updated
11 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 26474518

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bevacizumab and bevacizumab, erlotinib in people with Colorectal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 47 sites in 3 countries.

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

Who may be eligible to take part?

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 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in France, Canada, Austria. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression-free survival during maintenance therapy (time frame: Tumor evaluation every 2 months). 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 NCT00265824, which also lists 1 linked publication.

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 11 Dec 2015.

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