CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
bortezomib +3 moredrug
Likely dose
bortezomib 1.6 mg/m2from 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/NCT00425750
NCT00425750Phase 2Completed

Phase II Trial of Combination Weekly Bortezomib (VELCADE) and Docetaxel (TAXOTERE) in Patients With Recurrent and/ or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Vanderbilt-Ingram Cancer Center·interventional·Posted Jan 23, 2007·Updated Nov 16, 2011

In Brief

A Phase 2 clinical trial evaluating bortezomib, docetaxel, and 2 other interventions for Head and Neck Cancer. Completed, enrolled 25 participants across 7 sites.

Detailed Summary

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It 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. Giving bortezomib together with docetaxel may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with docetaxel works in treating patients with recurrent or metastatic head and neck cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 23, 2007
Enrollment StartAug 1, 2005
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 19.4 years ago

Interventions

bortezomibdrug

1.6 mg/m2 through a vein on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.

docetaxeldrug

40 mg/m2 through a vein on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1.

laboratory biomarker analysisother

Tissue and blood collection.

pharmacological studyother

Blood collection.