drugset / Trial / NCT00485485

Imatinib Mesylate (Gleevec) and Docetaxel in Patients With Head and Neck Squamous Cell Cancer

NCT00485485 ↗

Phase 2 Completed 7 enrolled M.D. Anderson Cancer Center Novartis · collab
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2007-01
Primary completion
2010-03
Completion
2010-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 60 mg/m2 Intravenous
Subject Imatinib Small molecule 400 mg Oral