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)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group; Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
• Treatments: Bevacizumab; Erlotinib Hydrochloride

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