CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
bevacizumab +3 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/NCT00281840
NCT00281840Phase 2Completed

A Phase II Study of Bevacizumab in Combination With Docetaxel and Radiation in Locally Advanced Squamous Cell Cancer of the Head and Neck

Case Comprehensive Cancer Center·interventional·Posted Jan 25, 2006·Updated Jun 9, 2015

In Brief

A Phase 2 clinical trial evaluating bevacizumab, docetaxel, and 2 other interventions for Head and Neck Cancer. Completed, enrolled 30 participants across 6 sites.

Detailed Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, 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 bevacizumab together with docetaxel and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel and radiation therapy works in treating patients with stage III or stage IV head and neck cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 25, 2006
Enrollment StartSep 1, 2005
Primary CompletionApr 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 20.4 years ago

Interventions

bevacizumabbiological

Bevacizumab IV over 30-90 minutes once every 2 weeks for up to 1 year. Bevacizumab, which stops 8 weeks before surgery, may restart 4 weeks after surgery and continue for 9 months in the absence of disease progression or unacceptable toxicity.

docetaxeldrug

docetaxel IV over 1 hour once a week for 8 weeks

conventional surgeryprocedure

8-10 weeks after the completion of chemoradiotherapy, patients may undergo neck dissection

radiation therapyradiation

radiotherapy once daily, 5 days a week, for 8 weeks