CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 7 enrolled
Drug / intervention
Cyclophosphamide +1 moredrug
Likely dose
Cyclophosphamide 50 mgfrom 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/NCT01581970
NCT01581970Phase 2Completed
CompareCT.gov

Potentiation of Cetuximab by Tregs Depletion With Metronomic Cyclophosphamide in Metastatic Squamous Cell Cancers of Head and Neck

Masonic Cancer Center, University of Minnesota·interventional·Posted Apr 20, 2012·Updated Sep 11, 2019

In Brief

A Phase 2 clinical trial evaluating Cyclophosphamide and Cetuximab for Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma. Completed, enrolled 7 participants across 1 site.

Detailed Summary

This is a feasibility study to assess the effectiveness of cetuximab when administered with low dose oral cyclophosphamide. Patients with metastatic squamous cell cancer of head and neck who have progressed on first line chemotherapy other than a cetuximab containing regimen will be treated with standard of care weekly cetuximab and twice daily low dose oral cyclophosphamide for 12 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer, Head and Neck Squamous Cell Carcinoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 20, 2012
Enrollment StartJun 1, 2012
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.2 years ago

Interventions

Cyclophosphamidedrug

Patients will be given oral cyclophosphamide 50 mg twice daily to be self-administered starting the first day of therapy with weekly cetuximab for 12 weeks or until disease progression.

Cetuximabdrug

The initial dose of cetuximab 400 mg/m\^2 is administered over 120 minutes followed by weekly infusions of cetuximab 250 mg/m\^2 intravenously (IV) over 60 minutes.