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)
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.
Drug: bevacizumab, erlotinib
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Progression-free survival during maintenance therapy [ Time Frame: Tumor evaluation every 2 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2005|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: bevacizumab alone||
bevacizumab 7.5mg/kg every 3 weeks until disease progression or limiting toxicity
|Experimental: Bevacizumab + erlotinib||
Drug: bevacizumab, erlotinib
bevacizumab 7.5mg/kg and oral erlotinib 150 mg/day continuously Cycles every 3 weeks until disease progression or limiting toxicity
- Compare Progression-free survival during maintenance period ("Maintenance PFS")in patients with unresectable metastatic colorectal cancer.
- 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.
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265824
Show 47 Study Locations
|Study Chair:||Aimery de Gramont, MD||Hopital Saint Antoine|
|Study Chair:||Christophe Tournigand, MD||Hopital Henri Mondor|