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Phase I and pharmacologic study of OSI-774, an epidermal growth factor receptor tyrosine kinase inhibitor, in patients with advanced solid malignancies.
TLDR
The recommended dose for disease-directed studies of OSI-774 administered orally on a daily, continuous, uninterrupted schedule is 150 mg/d, and several patients with epidermoid malignancies demonstrated either antitumor activity or relatively long periods of stable disease.
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Determinants of tumor response and survival with erlotinib in patients with non--small-cell lung cancer.
TLDR
Erlotinib was active and well tolerated in this patient population, and further clinical development is clearly warranted; cutaneous rash seems to be a surrogate marker of clinical benefit, but this finding should be confirmed in ongoing and future studies.
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Marked inactivation of O6-alkylguanine-DNA alkyltransferase activity with protracted temozolomide schedules
TLDR
P protracted administration of temozolomide, even at relatively low daily doses, leads to significant and prolonged depletion of AGAT activity, which may enhance the antitumour activity of the agent.
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ZD1839, a selective oral epidermal growth factor receptor-tyrosine kinase inhibitor, is well tolerated and active in patients with solid, malignant tumors: results of a phase I trial.
TLDR
ZD 1839 was well tolerated, with DLT observed at a dose well above that at which antitumor activity was seen, and Pharmacokinetic analysis confirmed that ZD1839 was suitable for administration as a once-daily oral tablet formulation.
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Cantuzumab mertansine, a maytansinoid immunoconjugate directed to the CanAg antigen: a phase I, pharmacokinetic, and biologic correlative study.
TLDR
The absence of severe hematologic toxic effects, preliminary evidence of cantuzumab mertansine tumor localization, and encouraging biologic activity in chemotherapy-refractory patients warrant further broad clinical development of this immunoconjugate in CanAg-expressing tumors.
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Phase I and pharmacokinetic study of temozolomide on a daily-for-5-days schedule in patients with advanced solid malignancies.
PURPOSE To determine the principal toxicities, characterize the pharmacokinetics (PKs) and pharmacodynamics (PDs) of temozolomide (TMZ) on a daily-for-5-days schedule, and recommend a dose for…
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Renal pathological findings in infective endocarditis.
TLDR
The kidneys are commonly affected in infective endocarditis by a variety of complications of clinical significance, and the commonest type of glomerulonephritis does not appear to be attributable to deposition of immune complexes, as well as vasculitic, without deposition of immunoproteins in glomeruli.
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A phase I study of pivaloyloxymethyl butyrate, a prodrug of the differentiating agent butyric acid, in patients with advanced solid malignancies.
TLDR
Dose escalation of AN-9 was limited by the maximum feasible volume of its intralipid formulation vehicle that could be administered safely on this schedule, resulting in a maximum deliverable dose of 3.3 g/m(2)/day.
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Phase I and pharmacokinetic study of pemetrexed administered every 3 weeks to advanced cancer patients with normal and impaired renal function.
TLDR
Pemetrexed was well tolerated at doses of 500 mg/m2 with vitamin supplementation in patients with GFR > or = 40 mL/min, and additional studies are needed to define appropriate dosing for renally impaired patients receiving higher dose pemetrexe with vitamin supplements.
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A Phase I Pharmacokinetic and Biological Correlative Study of Oblimersen Sodium (Genasense, G3139), an Antisense Oligonucleotide to the Bcl-2 mRNA, and of Docetaxel in Patients with…
TLDR
The absence of severe toxicities at this recommended dose, evidence of Bcl-2 protein inhibition in peripheral blood mononuclear cell(s) and tumor tissue, and encouraging antitumor activity in HPRC patients warrant further clinical evaluation of this combination.
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