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) (DREAM)
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|ClinicalTrials.gov Identifier: NCT00265824|
Recruitment Status : Completed
First Posted : December 15, 2005
Last Update Posted : December 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: bevacizumab Drug: bevacizumab, erlotinib||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||700 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||March 2012|
|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
- Progression-free survival during maintenance therapy [ Time Frame: Tumor evaluation every 2 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00265824
|Study Chair:||Aimery de Gramont, MD||Hopital Saint Antoine|
|Study Chair:||Christophe Tournigand, MD||Hopital Henri Mondor|