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• W2604179124 abstract "3053 Background: We sought to determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of the combination of OSI-774 (an EGFR inhibitor) and CPT-11 in patients (pts) with advanced solid tumors. Secondary aims included pharmacokinetic evaluation for drug interactions and analysis of relationship between UGT1A1 genotype and toxicity. Methods: Eligibility criteria included presence of tumors known to overexpress EGFR, ECOG performance scores 0–2, adequate hematologic, renal and hepatic function. Therapy was with daily continuous oral OSI-774 and intravenous CPT-11 every 3 weeks (which started on day 7 of OSI-774 therapy in cycle 1). DLTs were defined as grade 4 neutropenia, grade 3 thrombocytopenia or ≥ grade 3 non-hematologic toxicities despite maximal supportive care. The presence of the UGT1A1*28 polymorphism (either 6/7 or 7/7 promoter TA repeats) was ascertained. Results: 19 pts (median age 62) were enrolled. Tumor primaries were colon/rectum (8), lung (7), ovary (2), esophagus (1), and pancreas (1). Median number of previous therapies was 3 (Mean=4.7). 74 cycles were delivered (median 2). Dose de-escalations were necessary (table 1) per protocol. 9 non-dose-limiting, therapy-related ≥ 3 toxic events occurred: hematologic (2), fatigue (5), diarrhea (1), dehydration (1). DLTs occurred in 9 pts: diarrhea (7), nausea (3), melena (1), rash (1), neutropenia (3), and leukopenia (2). Protocol specific gastrointestinal or hematological DLT's were seen in 67% (6 of 9) pts with the *28 polymorphism and in only 20% (2/10) pts without it (2 sided p value= 0.07). No objective tumor responses were seen, however 3 pts had stable disease for >6 months. Pharmacokinetic data analysis is underway. Conclusions: The MTD of this combination has not yet been determined. The DLTs appear related to presence of UGT1A1 polymorphisms. Based on these results, a UGT1A1 genotype-specific dosing schedule is planned. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Pfizer" @default.
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• W2604179124 date "2004-07-15" @default.
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• W2604179124 title "Phase I trial of OSI-774 and CPT-11 in patients with advanced solid tumors" @default.
• W2604179124 doi "https://doi.org/10.1200/jco.2004.22.90140.3053" @default.
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