Spots Global Cancer Trial Database for Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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