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)

Phase 3

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: bevacizumab; Drug: bevacizumab, erlotinib

• Registration Number: NCT00265824
• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

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.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-12-14
• Study First Submitted QC: 2005-12-14
• Study First Posted: 2005-12-15
• Primary Completion: 2012-03
• Status Verified: 2014-03
• Last Update Submitted: 2015-12-10
• Last Update Posted: 2015-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bevacizumab alone	bevacizumab	-
Bevacizumab + erlotinib	bevacizumab, erlotinib	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival during maintenance therapy	Tumor evaluation every 2 months

Trial Locations

Locations (41)

LKH Leoben; 🇦🇹 Leoben, Austria

LKH Steyr; 🇦🇹 Steyr, Austria

Klinikum Wels-Grieskirchen GmbH; 🇦🇹 Wels, Austria

AKH Universitätsklinik für Innere Medizin I; 🇦🇹 Wien, Austria

Ottawa Hospital Regional Cancer Centre; 🇨🇦 Ottawa, Ontario, Canada

Cité de la Santé de Laval; 🇨🇦 Laval, Quebec, Canada

CHUM Hôpital Notre-Dame; 🇨🇦 Montreal, Quebec, Canada

Mc Gill University Hospital; 🇨🇦 Montreal, Quebec, Canada

Hôpital Charles LeMoyne; 🇨🇦 Montreal, Quebec, Canada

Hôpital Maisonneuve-Rosemont; 🇨🇦 Montréal, Quebec, Canada

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