CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 enrolled
Drug / intervention
cetuximab +3 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/NCT00833261
NCT00833261Phase 2Completed

A Phase II Multi-Center Study of Concomitant Cetuximab and Cisplatin With Re-Irradiation Using Intensity-Modulated Radiotherapy in Patients With Recurrent Squamous Cell Carcinoma of the Head-and-Neck

University of Texas Southwestern Medical Center·interventional·Posted Feb 2, 2009·Updated Aug 21, 2020

In Brief

A Phase 2 clinical trial evaluating cetuximab, cisplatin, and 2 other interventions for Head and Neck Cancer. Completed, enrolled 37 participants across 4 sites.

Detailed Summary

RATIONALE: 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. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab and cisplatin together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with recurrent head and neck cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2, 2009
Enrollment StartDec 1, 2008
Primary CompletionSep 1, 2013
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 17.4 years ago

Interventions

cetuximabdrug

cetuximab

cisplatindrug

cisplatin

intensity-modulated radiation therapyradiation

IMRT

Nab-Paclitaxeldrug

Nab-Paclitaxel