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Phase I clinical trial of bortezomib in combination with gemcitabine in patients with advanced solid tumors by David P. Ryan; Leonard J. Appleman; Thomas Lynch; Jeffrey G. Supko; Panagiotis Fidias; Jeffrey W. Clark; Mayer Fishman; Andrew X. Zhu; Peter C. Enzinger; Oscar Kashala; James Cusack Jr.; Joseph P. Eder is a Medicine article available to read on EtoBox.
What is Phase I clinical trial of bortezomib in combination with gemcitabine in patients with advanced solid tumors about?
## Abstract ## BACKGROUND. Bortezomib is the first proteasome inhibitor to show preliminary evidence of activity against solid tumors. Findings from preclinical studies prompted a Phase I trial to determine the maximum tolerated dose (MTD) and dose‐limiting toxicities (DLTs) of bortezomib in combination with gemcitabine in patients with recurring/refractory advanced solid tumors. The effect of gemcitabine on proteasome inhibition by bortezomib in whole blood was also investigated. ## METHODS. Bortezomib was administered as an intravenous bolus injection on Days 1, 4, 8, and 11, with gemcitabine (30‐minute infusion) on Days 1 and 8 of a 21‐day cycle. Groups of ≥3 patients were evaluated at each dose level. Escalating doses of gemcitabine 500 mg/m^2^ to 1000 mg/m^2^ with bortezomib 1.0 mg/m^2^ to 1.5 mg/m^2^ were planned. ## RESULTS. There were no DLTs in patients receiving bortezomib 1.0 mg/m^2^ and gemcitabine 500 mg/m^2^ to 1000 mg/m^2^ in the first 3 dose levels. Dose‐limiting nausea, vomiting, gastrointestinal obstruction, and thrombocytopenia occurred in 4 of 5 evaluable patients in dose level 4 (bortezomib 1.3 mg/m^2^, gemcitabine 800 mg/m^2^), establishing bortezomib 1.0 mg/m
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- Author
- David P. Ryan; Leonard J. Appleman; Thomas Lynch; Jeffrey G. Supko; Panagiotis Fidias; Jeffrey W. Clark; Mayer Fishman; Andrew X. Zhu; Peter C. Enzinger; Oscar Kashala; James Cusack Jr.; Joseph P. Eder
- Publisher
- John Wiley and Sons; Wiley (John Wiley & Sons); John Wiley & Sons Inc.; Wiley (ISSN 0008-543X)
- Published
- 2006
- Language
- EN
- Field
- Medicine (Health Sciences)