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)

Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Study ID
NCT00265824
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — DRUG
    bevacizumab 7.5mg/kg every 3 weeks until disease progression or limiting toxicity
  • bevacizumab, erlotinib — DRUG
    bevacizumab 7.5mg/kg and oral erlotinib 150 mg/day continuously Cycles every 3 weeks until disease progression or limiting toxicity

Study Details

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.

Key Dates

First listed
Dec 15, 2005
Start date
May 31, 2005
Status verified
Mar 2014
Primary completion
Mar 31, 2012

Study Design

Enrollment
700 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: bevacizumab alone
  • Experimental: Bevacizumab + erlotinib

Primary Outcome Measure

Progression-free survival during maintenance therapy [ Time Frame: Tumor evaluation every 2 months ]

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