CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Cetuximab +2 moredrug
Likely dose
Not stated in 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/NCT01412229
NCT01412229Phase 2Completed
CompareCT.gov

A Phase II Study of Carboplatin, Nab-paclitaxel and Cetuximab for Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

UNC Lineberger Comprehensive Cancer Center·interventional·Posted Aug 9, 2011·Updated Nov 23, 2020

In Brief

A Phase 2 clinical trial evaluating Cetuximab, Nab-paclitaxel, and 1 other intervention for Head and Neck Cancer. Completed, enrolled 40 participants across 3 sites.

Detailed Summary

This is a non-randomized, open-label phase II trial of 40 patients with poor prognosis head and neck cancer, defined as surgically unresectable and/or ≥N2b disease and judged appropriate for non-surgical definitive therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer
CountriesUnited States
CollaboratorsCelgene Corporation

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 9, 2011
Enrollment StartFeb 1, 2012
Primary CompletionJun 20, 2015
Study CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 14.9 years ago

Interventions

Cetuximabdrug

Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.

Nab-paclitaxeldrug

Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.

Carboplatindrug

Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.