CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
paclitaxel albumin-stabilized nanoparticle formulation +5 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/NCT01566435
NCT01566435Phase 2Completed

Phase II Trial of Nab-Paclitaxel, Cisplatin, and 5-FU (ACF) as Induction Therapy Followed by Definitive Concurrent Chemoradiation for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (HNSCC)

Washington University School of Medicine·interventional·Posted Mar 29, 2012·Updated Oct 1, 2020

In Brief

A Phase 2 clinical trial evaluating paclitaxel albumin-stabilized nanoparticle formulation, Cisplatin, and 4 other interventions for Head and Neck Neoplasms. Completed, enrolled 30 participants across 1 site.

Detailed Summary

This phase II trial studies the safety and effectiveness of an induction chemotherapy (ACF) consisting of paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel), cisplatin and fluorouracil followed by chemoradiation therapy in treating patients with stage III-IV squamous cell cancer of the head and neck. ACF may be an effective way to reduce or downgrade locally aggressive tumors, and improve the chance of eradication by chemoradiation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsCelgene

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 29, 2012
Enrollment StartAug 9, 2012
Primary CompletionOct 31, 2013
Study CompletionOct 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.3 years ago

Interventions

paclitaxel albumin-stabilized nanoparticle formulationdrug

Cisplatindrug

Fluorouracildrug

Intensity modulated radiation therapyradiation

Cetuximabdrug

Quality-of-life assessmentprocedure

ACF baseline, IMRT baseline, Day 7, Week 12, months 6 and 12