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• W2241901312 abstract "5541 Background: OSI-774 is an inhibitor of the epidermal growth factor receptor tyrosine kinase that has activity in SCCHN. Docetaxel is active in SCCHN and has moderate toxicity when administered on a weekly schedule. We sought to determine the maximum tolerated dose (MTD) of OSI-774/weekly docetaxel in SCCHN. Methods: Patient (pt) eligibility: measurable recurrent or metastatic SCCHN considered incurable by surgery or radiation; ≤ 1 prior chemotherapy; ECOG performance status (PS) ≤ 2. Treatment regimen: oral OSI-774 daily for 28 day cycle; docetaxel on days 8, 15 and 22; cycle repeated every 28 days to a maximum of 6 cycles. Cohorts of 3–6 pts in each dose level. Plasma levels of OSI-774 and active metabolite OSI-420 were measured on Day 1 and 8. Results: To date, 15 patient have been enrolled with the following characteristics: (medians) age 57 years (range 24–78); PS 1 (range 0–2); 5 pts with prior chemotherapy. Initial dose level was 50mg:35mg/m2 (OSI-774:docetaxel) with no dose limiting toxicity (DLT) in cohort. Second cohort treated with 100mg:35mg/m2, two patients had DLT (one with rash and one with neutropenia/sepsis). Subsequent dose was lowered to 100mg:25mg/m2 and two of six pts developed DLT (one with rash and one with stomatitis). Fourth cohort was treated at 50mg:25mg/m2 dose. One of three pts developed unexplained pulmonary complications and 3 pts will be added to this cohort. In total, nine pts have experienced rash, two at grade 3 level. Twelve pts are response-evaluable; 4 partial responses, 6 with stable disease, 2 with disease progression. Three pts were not evalauble due to adverse event. Pharmacokinctic data does not explain need for lower dose in this combination. Conclusions: OSI-774/docetaxel is active regimen in SCCHN. The MTD is yet to be determined, but dose of combination therapy appears to be lower then single agent therapy with either drug. Biological correlative studies have been initiated. Patient accural continues with plan to proceed to phase II once MTD is determined. Updated data including pharmacokinetics and biological correlates will be presented. Disclosure: Trial supported by National Cancer Institute, grant #2 U01 CA 76576–06. No significant financial relationships to disclose." @default.
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• W2241901312 date "2004-07-15" @default.
• W2241901312 modified "2023-10-04" @default.
• W2241901312 title "Phase I and II study of OSI-774 and docetaxel in squamous cell carcinoma of the head and neck (SCCHN)" @default.
• W2241901312 doi "https://doi.org/10.1200/jco.2004.22.90140.5541" @default.
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