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)

Colorectal Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00265824
• Other study ID #: CDR0000453861
• Secondary ID: GERCOR-C04-2EU-2
• Status: Completed
• Phase: Phase 3
• First received: December 14, 2005
• Last updated: December 10, 2015
• Start date: May 2005

Study information

• Verified date: March 2014
• Source: Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : Agence Française de Sécurité Sanitaire et Produits de Santé (AFSSAPS)
• Study type: Interventional

Clinical 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 treating patients with metastatic colorectal cancer that cannot be removed by surgery.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Austria	LKH Leoben	Leoben
Austria	LKH Steyr	Steyr
Austria	Klinikum Wels-Grieskirchen GmbH	Wels
Austria	AKH Universitätsklinik für Innere Medizin I	Wien
Canada	Cité de la Santé de Laval	Laval	Quebec
Canada	CHUM Hôpital Notre-Dame	Montreal	Quebec
Canada	Hôpital Charles LeMoyne	Montreal	Quebec
Canada	Mc Gill University Hospital	Montreal	Quebec
Canada	Hôpital Maisonneuve-Rosemont	Montréal	Quebec
Canada	Ottawa Hospital Regional Cancer Centre	Ottawa	Ontario
France	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	Clinique de la sauvegarde	Lyon
France	Hôpital Privé Jean Mermoz	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	Groupe Hospitalier les Diaconnesses	Paris
France	Hôpital Pitié Salpêtrière	Paris
France	Hopital Saint Antoine	Paris
France	Hôpital Saint Joseph	Paris
France	Hopital Tenon	Paris
France	Institut Curie	Paris
France	Institut Mutualiste Montsouris	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

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Countries where clinical trial is conducted

Austria,  Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival during maintenance therapy		Tumor evaluation every 2 months	No