Clinical Trials Directory

Trials / Completed

CompletedNCT00049283

Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer

A Phase I Study of the Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, OSI-774, in Combination With Docetaxel and Radiation in Locally Advanced Squamous Cell Cancer of the Head and Neck

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
30 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining erlotinib with docetaxel may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells. Phase I trial to study the maximum tolerated dose (MTD) of combining erlotinib with docetaxel and radiation therapy in treating patients who have locally advanced head and neck cancer

Detailed description

PRIMARY OBJECTIVES: I. Determine MTD and toxicity of combination of EGFR inhibitor (OSI-774), docetaxel, and radiation. II. Pharmacokinetic profile of OSI-774 alone and in combination with docetaxel. SECONDARY OBJECTIVES: I. Determine the overall and complete response rate of this combination. II. Determine overall, disease free, and progression free survival of this combination. * EGFR expression and phosphorylation status * Serum markers of angiogenic activity VEGF, sVEGFR-2, sKIT, ICAM, PDGF * Fluorescence in situ hybridization (FISH) for EGFR, ERBB2, PDGFR-β for gene amplification * DNA-sequencing of EGFR and ERBB2 genes from DNA extracted from pretreatment biopsy material for mutation screening * Gene expression profiling on pre-treatment biopsy material to identify predictors of response to treatment * Apoptosis (TUNEL assay) * Ki67 (nuclear proliferation antigen). OUTLINE: This is a dose-escalation study of erlotinib and docetaxel. Patients receive oral erlotinib alone daily on weeks 1 and 2. Patients then receive oral erlotinib daily beginning on day 1 and docetaxel IV over 1 hour on day 3 of weeks 3-9. Patients also undergo radiotherapy once daily 5 days a week on weeks 3-9. Patients continue erlotinib for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients who had N2 or greater cervical lymph node involvement at baseline or have residual neck adenopathy after chemoradiotherapy undergo neck dissection 6-8 weeks after completion of chemoradiotherapy. Erlotinib is held for 1 week before planned surgery and until healing is complete. Cohorts of 3-6 patients receive escalating doses of erlotinib and docetaxel until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 16 weeks for 1 year after completion of erlotinib, every 24 weeks for 2 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Conditions

Interventions

TypeNameDescription
DRUGerlotinib hydrochlorideGiven orally
DRUGdocetaxelGiven IV
RADIATIONradiation therapyUndergo radiotherapy
PROCEDUREtherapeutic conventional surgeryUndergo neck dissection
OTHERlaboratory biomarker analysisCorrelative studies
OTHERpharmacological studyCorrelative studies

Timeline

Start date
2002-09-01
Primary completion
2008-02-01
Completion
2008-02-01
First posted
2003-01-27
Last updated
2014-06-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00049283. Inclusion in this directory is not an endorsement.