A phase I study of flavopiridol and docetaxel. Year: 2003 Abstract No: 932 Category: Other Novel Agents Author(s): B. Patel, B. F. El-Rayes, S. M. Gadgeel, P. Lorusso, P. A. Philip; Karmanos Cancer Institute, Detroit, MI Abstract: Flavopiridol is a cell cycle inhibitor with activity against several cyclin dependent kinases. In preclinical models, flavopiridol has been shown to potentiate the activity of other cytotoxic agents including taxanes. This synergistic interaction is sequence dependent such that mitotic entry and cdc-2 kinase activation by taxanes must precede flavopiridol therapy. The primary objective of this Phase I study was to determine the maximum tolerated dose (MTD) of flavopiridol and docetaxel. Eligible patients were age 18 years or older, had histologic or cytologic diagnosis of non-hematologic cancer resistant to conventional treatment, life expectancy of more than 3 months, normal renal, hepatic and bone marrow function, and a SWOG performance status of 0 to 2. Docetaxel was administered intravenously over 60 minutes on day 1 and flavopiridol by continuous infusion over 24 hours on day 2 of a 21-day cycle. Both flavopiridol and docetaxel doses were started at the first dose level of 60 mg/m2 of both drugs. Ten patients (9 Caucasians; mean age 56 years, range 39-67 years) have been treated. The median number of treatment cycles was 2 (range 1-6) with a total of 20 cycles. Two of the three patients treated at the starting dose level developed dose limiting toxicity (DLT) that resulted in neutropenic fever. Subsequently 7 patients were treated at dose level -1 (docetaxel/flavopiridol: 60 mg/m2/50 mg/m2). One DLT was observed at level -1 that was diarrhea. No treatment related mortality has been observed. Of the 10 patients, 1 (10%) patients have stable disease. The MTD of the 3-weekly combination of flavopiridol and docetaxel is 50 mg/m2 and 60 mg/m2, respectively. Supported by UO-1 grant CA 62487. Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.