CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 230 enrolled
Drug / intervention
Bevacizumab +4 moredrug
Likely dose
Bevacizumab 5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01718873
NCT01718873Phase 3Completed

Randomized Phase 3 Study on the Optimization of Bevacizumab With mFOLFOX/mOXXEL in the Treatment of Patients With Metastatic Colorectal Cancer

National Cancer Institute, Naples·interventional·Posted Oct 31, 2012·Updated Apr 12, 2023

In Brief

A Phase 3 clinical trial evaluating Bevacizumab, Oxaliplatin, and 3 other interventions for Colorectal Cancer. Completed, enrolled 230 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate if giving bevacizumab prior to chemotherapy compared to giving bevacizumab at the same time as chemotherapy improves patient overall response to treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 31, 2012
Enrollment StartMay 1, 2012
Primary CompletionDec 1, 2015
Study CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 13.7 years ago

Interventions

Bevacizumabdrug

5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.

Oxaliplatindrug

85mg/m2 IV every 2 weeks for up to 24 weeks

levo-folinic aciddrug

200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks

5-fluorouracildrug

400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)

Capecitabinedrug

1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)