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  

Colorectal Cancer Clinical Trial

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

Status Completed

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.

Clinical Trial 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 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

• NCT number: NCT00265824
• Study type: Interventional
• Source: Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
• Status: Completed
• Phase: Phase 3
• Start date: May 2005