First-line FOLFOXIRI In Combination With Bevacizumab For Metastatic Colorectal Cancer (FOIB)
|ClinicalTrials.gov Identifier: NCT01163396|
Recruitment Status : Completed
First Posted : July 15, 2010
Last Update Posted : March 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic||Drug: Bevacizumab Drug: Irinotecan Drug: Oxaliplatin Drug: 5-fluorouracil/leucovorin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label, Multicenter, Phase II Study Of First-line Biweekly Irinotecan, Oxaliplatin And Infusional 5-FU/LV (FOLFOXIRI) In Combination With Bevacizumab In Patients With Metastatic Colorectal Cancer|
|Study Start Date :||July 2007|
|Primary Completion Date :||April 2009|
|Study Completion Date :||April 2010|
Experimental: FOLFOXIRI plus bevacizumab
BEVACIZUMAB 5 mg/Kg i.v. followed by IRINOTECAN 165 mg/sqm i.v. over 1 hr followed by OXALIPLATIN 85 mg/sqm i.v. over 2 hr concomitantly with l-LV 200 mg/sqm over 2 hrs followed by 5FU 3.200 mg/sqm c.i. over 48 hrs starting on day 1. Cycles repeated every 2 weeks
|Drug: Bevacizumab Drug: Irinotecan Drug: Oxaliplatin Drug: 5-fluorouracil/leucovorin|
- Progression-free survival (PFS) [ Time Frame: PFS rate at 10 months from study entry ]PFS was calculated from the day of treatment start to the first observation of disease progression or death from any cause.
- Response rate (RR) [ Time Frame: 2007-2010 ]Response evaluation was performed every 8 weeks from the day of treatment start until disease progression for each enrolled patient for the full lenght of the study. Response evaluation was performed according to RECIST criteria. Responses were subsequently confirmed by a central review.
- Overall survival (OS) [ Time Frame: 2007-2010 ]OS was calculated from the day of treatment start until death from any cause for each enrolled patient for the full lenght of the study, censoring patients who had not died at the last date known to be alive.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 2007-2010 ]During the full lenght of first-line treatment, number of enrolled patients reporting adverse events was recorded. Adverse events were evaluated according to National Cancer Institute Common Toxicity Criteria (version 3.0).
- Evaluation of potential surrogate markers predictive of bevacizumab activity [ Time Frame: 2007-2010 ]During first-line therapy and at disease progression.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163396
|Principal Investigator:||Alfredo Falcone, MD||University of Pisa|