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)

GERCOR - Multidisciplinary Oncology Cooperative Group700 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (47)

LKH Leoben

Leoben, Austria

LKH Steyr

Steyr, Austria

AKH Universitätsklinik für Innere Medizin I

Vienna, Austria

Klinikum Wels-Grieskirchen GmbH

Wels, Austria

Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, Canada

Cité de la Santé de Laval

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)

Overview

Conditions

Interventions

Eligibility

Locations (47)

Outcomes

Primary Outcomes