The overall objectives for the Pharmacology and Experimental Therapeutics (PET) Committee of the CALGB are to study population pharmacokinetics and pharmacodynamics of new and established anticancer agents in a multi-institutional setting; to introduce new drugs and combinations, including immunomodulatory and cytostatic agents into the CALGB for eventual phase II and III testing; to initiate and conduct a program of mucositis prevention in the CALGB; and to organize educational symposia for the Group on topics in cancer pharmacology and experimental therapeutics. The committee meets twice annually in addition to sponsoring an educational session at each of the full Group meetings. Population pharmacology are ongoing of suramin, carboplatin, paclitaxel, 9-aminocamptothecin, 5-fluorouracil and etoposide. Studies are planned of irinotecan and docetaxel, in addition to two additional studies of paclitaxel with regard to the effects of age and body surface on toxicity and pharmacokinetics, Other special populations to be studied include race (docetaxel and irinotecan) and end-organ dysfunction (gemcitabine, irinotecan). Two novel therapeutic studies involving biologics are planned, including IL-2 in combination with an anti-HER-2 monoclonal antibody and interferon alpha in combination with tamoxifen. Another new initiative is a program to prevent mucositis. The initial study will evaluate the effect of IL-11 on mucositis secondary to cisplatin, 5-FU and leucovorin. Since many of the studies include analysis of pharmacological specimens, the Committee utilizes three core laboratories--at the University of Chicago, the University of Maryland and the University of Tennessee.
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