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 Group

Status and phase

Completed

Phase 3

Conditions

Colorectal Cancer

Treatments

Drug: bevacizumab, erlotinib

Drug: bevacizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT00265824

GERCOR-OPTIMOX3

EU-20565

GERCOR-DREAM- C04-2

GERCOR-C04-2

CDR0000453861

Details and patient eligibility

About

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.

Full 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.

Enrollment

700 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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