Phase I Study of Weekly Docetaxel and Liposomal Doxorubicin in Patients with Advanced Solid TumorsKouroussis C.a · Androulakis N.b · Vamvakas L.b · Kalykaki A.b · Spiridonakou S.a · Kentepozidis N.a · Saridaki Z.a · Xiropoulou El.b · Georgoulias V.a
aFirst Department of Medical Oncology, ‘Theagenion’ Anticancer Hospital, Thessaloniki, and bDepartment of Medical Oncology, University General Hospital of Heraklion, Heraklion, Greece
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Purpose: To determine the maximum-tolerated doses (MTDs) and the dose-limiting toxicities (DLTs) of the weekly administration of docetaxel and pegylated liposomal doxorubicin (PEG-LD) in patients with advanced solid tumors. Patients and Methods: Forty-eight patients with solid tumors were enrolled in the study. Dose escalations of both drugs were given on a weekly basis for 3 consecutive weeks in cycles of 4 weeks. The starting dose for docetaxel was 20 mg/m2/week and for PEG-LD 6 mg/m2/week. Results: The MTD was 35 mg/m2/week for docetaxel and 14 mg/m2/week for PEG-LD. The DLTs at this level were grade 3 diarrhea (n = 1 patient) and grade 3 mucositis (n = 2 patients). There was no grade 4 hematologic or non-hematologic toxicity. Grade 3 neutropenia and thrombocytopenia occurred only in 1 and 2 patients, respectively. The non-hematologic toxicity was also mild with grade 2/3 fatigue in 8 patients, grade 2/3 neurotoxicity in 4, grade 2/3 mucositis in 8, grade 2/3 diarrhea in 4 and grade 2/3 nausea and vomiting in 5 patients. Two (5.7%) complete and 6 (17%) partial responses (overall response rate = 22.7%; 95% confidence interval 9.6–32.4%) were observed among 35 evaluable patients. In 12 (63%) of 19 patients with hormone-refractory prostate cancer, a decline in serum levels of prostate-specific antigen of >50% was observed. Conclusions: The weekly administration of docetaxel with PEG-LD is a well-tolerated regimen that merits further evaluation.
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