CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 108 enrolled
Drug / intervention
Dose escalation of cetuximab +1 moredrug
Likely dose
Dose escalation of cetuximab 400 mg/m2from 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/NCT01251536
NCT01251536Phase 2Completed
CompareCT.gov

A Two Arm Phase II Study of FOLFIRI in Combination With Standard or Escalating Dose of Cetuximab as First Line Treatment of K-Ras Wild Type Metastatic Colorectal Cancer: Everest 2

Universitaire Ziekenhuizen KU Leuven·interventional·Posted Dec 2, 2010·Updated Oct 11, 2019

In Brief

A Phase 2 clinical trial evaluating Dose escalation of cetuximab and Standard first line treatment with cetuximab + Folfiri for Colorectal Cancer. Completed, enrolled 108 participants across 30 sites in 5 countries.

Detailed Summary

The purposes of this study are to determine whether administering escalating doses of cetuximab in patients with no early skin toxicity could delay the progression of disease in a significant proportion of patients and to study the molecular signatures of response.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer
CountriesAustria, Belgium, France, Hungary, Spain
CollaboratorsMerck KGaA, Darmstadt, Germany

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2, 2010
Enrollment StartDec 1, 2010
Primary CompletionJun 1, 2016
Study CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 15.6 years ago

Interventions

Dose escalation of cetuximabdrug

Dose, frequency \& treatment mode: 400 mg/m2 (loading at day 1) followed by 250 mg/m2 weekly (at day 8 and 15) Arm allocation at day 22: Patients with skin toxicity grade 0 will follow an increasing dose schedule: on days 22 and 29 they will receive 350 mg/m2 and from day 36 onwards, 500 mg/m2 weekly

Standard first line treatment with cetuximab + Folfiridrug

Dose, frequency \& treatment mode: 400 mg/m2 (loading at day 1) followed by 250 mg/m2 weekly (at day 8 and 15) Arm allocation at day 22: Patients with skin toxicity grade 1-4 or other significant toxicity who are not eligible for dose escalation will continue on the standard dose of cetuximab: 250 mg/m2 weekly.