CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 7 enrolled
Drug / intervention
Imatinib Mesylate +1 moredrug
Likely dose
Imatinib Mesylate 400 mgfrom 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/NCT00485485
NCT00485485Phase 2Completed

Phase II Study of Imatinib Mesylate and Docetaxel in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Cancer

M.D. Anderson Cancer Center·interventional·Posted Jun 13, 2007·Updated Aug 7, 2012

In Brief

A Phase 2 clinical trial evaluating Imatinib Mesylate and Docetaxel for Head and Neck Cancer and Squamous Cell Cancer. Completed, enrolled 7 participants across 1 site.

Detailed Summary

Primary Objective: * To determine the efficacy of the combination of imatinib mesylate and docetaxel in recurrent or metastatic head and neck squamous cell cancer by serial measurements of tumor response (extent, frequency, duration). Secondary Objectives: * To assess the safety and tolerability of imatinib mesylate and docetaxel in patients with recurrent or metastatic head and neck squamous cell cancer. * To explore the biologic effects of imatinib mesylate and docetaxel on tumor tissue by immunohistochemical analysis of microvessel density and phosphorylation of Platelet-derived growth factor receptors (PDGF-R). * To explore the effects of imatinib mesylate and docetaxel on surrogate markers in serum. * To assess the rate of survival.

Study Details

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

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 13, 2007
Enrollment StartJan 1, 2007
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 19.1 years ago

Interventions

Imatinib Mesylatedrug

400 mg by mouth daily

Docetaxeldrug

60 mg/m\^2 by vein (IV) over 1 hour every 3 weeks