CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
Head and neck +1 moredrug
Likely dose
Head and neck 1.4mg/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/NCT01744340
NCT01744340Phase 2Completed
CompareCT.gov

A Dose Finding Study of Eribulin Mesylate and Cetuximab For Patients With Advanced Head and Neck and Colon Cancer With an Expansion Cohort For Head and Neck Cancer: A Brown University Oncology Research Group Study

howard safran·interventional·Posted Dec 6, 2012·Updated Feb 17, 2020

In Brief

A Phase 2 clinical trial evaluating Head and neck and Colon- Closed as of May 2014 for Head and Neck Cancer and Colon Cancer. Completed, enrolled 23 participants across 4 sites.

Detailed Summary

The purpose of this study is to determine if the full dose of eribulin mesylate can be safely given with the full dose of cetuximab. The activity of the combination of eribulin mesylate and cetuximab on recurrent head and neck cancer and colon cancer will also be assessed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer, Colon Cancer
CountriesUnited States
CollaboratorsFatima Memorial Hospital, Montefiore Medical Center, Rhode Island Hospital, The Miriam Hospital

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 6, 2012
Enrollment StartMay 1, 2012
Primary CompletionMar 1, 2015
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.6 years ago

Interventions

Head and neckdrug

Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle

Colon- Closed as of May 2014drug

Eribulin Mesylate: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle