CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
ZD6474 +1 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/NCT00459043
NCT00459043Phase 2Completed

Randomized Phase II Study of Docetaxel in Combination With Zactima (ZD6474) in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Dana-Farber Cancer Institute·interventional·Posted Apr 11, 2007·Updated Jul 3, 2013

In Brief

A Phase 2 clinical trial evaluating ZD6474 and Docetaxel for Squamous Cell Carcinoma of Head and Neck. Completed, enrolled 30 participants across 3 sites.

Detailed Summary

In this research study, the researchers are comparing the combination of docetaxel and Zactima with docetaxel alone to see if the combination of the two drugs will be more effective than docetaxel alone. Zactima blocks the actions of three substances in the body: 1)vascular endothelial growth factor reception (VEGFR); 2)epidermal growth factor receptor (EGFR); and 3) rearranged during transfection (RET). VEGFR stimulates the growth of new blood vessels. When certain proteins bind to the VEGF receptor, a process begins to occur which allows new blood vessels to be made that provide blood to the cancer cells. Zactima is thought to block these proteins from binding to the VEGF receptor, which would then block the process that creates new blood vessels. EGFR controls how quickly cells grow and multiply. RET is thought to have a particularly significant role in the development and growth of squamous cell tumors. The actions of Zactima are very different from the way standard chemotherapy drugs work. Researchers believe that Zactima might have different side effects from other cancer treatments so another one of the purposes of this study is to assess the side effects caused by the drug.

Study Details

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

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 11, 2007
Enrollment StartMar 1, 2007
Primary CompletionMar 1, 2010
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 19.2 years ago

Interventions

ZD6474drug

Taken orally once every morning

Docetaxeldrug

Given on the first day of every treatment cycle (every 3 weeks)