CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
cetuximab +8 morebiological
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/NCT00721513
NCT00721513Phase 2Completed

Phase II Study to Evaluate the Efficacy and Toxicity of Multimodality Treatment With Induction Taxotere/Cisplatin?5-FU (TPF) Chemotherapy Followed by Concomitant Cetuximab and Radiation Therapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Wake Forest University Health Sciences·interventional·Posted Jul 24, 2008·Updated Apr 7, 2020

In Brief

A Phase 2 clinical trial evaluating cetuximab, cisplatin, and 7 other interventions for Head and Neck Cancer. Completed, enrolled 20 participants across 1 site.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with cetuximab and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel, cisplatin, and fluorouracil together with cetuximab and radiation therapy works in treating patients with locally advanced head and neck cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 24, 2008
Enrollment StartSep 1, 2008
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 17.9 years ago

Interventions

cetuximabbiological

cisplatindrug

docetaxeldrug

fluorouracildrug

computed tomographyprocedure

positron emission tomographyprocedure

quality-of-life assessmentprocedure

3-dimensional conformal radiation therapyradiation

intensity-modulated radiation therapyradiation