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• W2247881204 abstract "14061 Background: No standard therapies are available for HCC patients (pts) who are not eligible for curative treatments (surgery, RF, TACE or PEI). Methods: This dose finding phase I/II study investigates the tolerability of increasing doses of continuous HAI of CPT-11 (during days 1–5 every 21) in pts with histologically confirmed Child A/B HCC, confined to the liver, not eligible for curative treatments. Secondary endpoints are pharmacokinetics and efficacy. To date, 5 dose levels (DL) of CPT-11 have been investigated (from 7,5 to 17,5 mg/m 2 /die) and the 6 th (20 mg/m 2 /die) being evaluated. An arterial port-a-cath was placed in the hepatic artery by percutaneous catheterization of the femoral or axillary artery. Before each cycle an angiography was performed to define the optimal liver perfusion. DLT was defined as one G4 hematogical and/or two G3 nonhematological toxicities or liver function impairment (Child C). AEs were graded using NCI-CTC. Responses were evaluated after the 3 rd cycle with ultrasonography or CT scan (WHO criteria). Results: To date 16 pts have been enrolled and evaluated for tolerability. Median age is 63, 8 years (range 41–80), M/F 11/5, median ECOG 1 (0–2), Child-Pugh A/B 10/6 . Total n° of courses was 41 (median 2, range 1–10). DLT was not reached. Two grade 3 toxicities were reported at DL 4: diarrhea in 1 pt and anemia in another pt. There were no G4 toxicities. Most common G1–2 toxicities at any DL were: neutropenia 5 pts (31%), nausea/vomiting 4 pts (25%), diarrhea 3 pts (18%), thrombocytopenia 2 pts (12.5%). In two pts (DL3 and DL4) treatment was discontinued because of chemotherapy induced arteritis after 1 and 3 courses respectively. 12 pts were assessable for response: 3 PR, 6 SD, 3 PD. α-fetoprotein levels decreased significantly in 6 pts (50%). Pharmacokinetics data will be presented later. Conclusions: To date MTD hasn’t been reached. At DL 1–5 this schedule shows little and manageable toxicity - without impairment of liver function - and promising activity (PR+SD=75%). No significant financial relationships to disclose." @default.
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• W2247881204 date "2006-06-20" @default.
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• W2247881204 title "Phase I/II trial of continuous hepatic arterial infusion (HAI) of Irinotecan in patients with hepatocellular carcinoma (HCC). Preliminary results" @default.
• W2247881204 doi "https://doi.org/10.1200/jco.2006.24.18_suppl.14061" @default.
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