CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 204 enrolled
Drug / intervention
erlotinib hydrochloride +4 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/NCT00410826
NCT00410826Phase 2Completed

Multicenter Randomized Phase II Study of Erlotinib, Cisplatin and Radiotherapy Versus Cisplatin and Radiotherapy in Patients With Stage III and IV Squamous Cell Carcinoma of the Head and Neck

University of Washington·interventional·Posted Dec 13, 2006·Updated May 10, 2013

In Brief

A Phase 2 clinical trial evaluating erlotinib hydrochloride, cisplatin, and 3 other interventions for Stage III Squamous Cell Carcinoma of the Hypopharynx and 9 related conditions. Completed, enrolled 204 participants across 9 sites.

Detailed Summary

This randomized phase II trial is studying cisplatin and radiation therapy together with or without erlotinib hydrochloride to compare how well they work in treating patients with stage III or stage IV head and neck cancer. 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. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also make tumor cells more sensitive to radiation therapy. Giving cisplatin and radiation therapy together with erlotinib hydrochloride may kill more tumor cells. It is not yet known whether cisplatin and radiation therapy are more effective with or without erlotinib hydrochloride in treating head and neck cancer

Study Details

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 13, 2006
Enrollment StartJun 1, 2006
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 19.6 years ago

Interventions

erlotinib hydrochloridedrug

Given orally

cisplatindrug

Given IV

3-dimensional conformal radiation therapyradiation

35 fractions

intensity-modulated radiation therapyradiation

35 fractions

quality-of-life assessmentprocedure

Ancillary studies