Phase I trial of bortezomib and concurrent external beam radiation in patients with advanced solid malignancies

International Journal of Radiation Oncology, Biology, Physics
Thomas J PughDavid Raben

Abstract

To determine the maximal tolerated dose of bortezomib with concurrent external beam radiation therapy in patients with incurable solid malignant tumors requiring palliative therapy. An open label, dose escalation, phase I clinical trial evaluated the safety of three dose levels of bortezomib administered intravenously (1.0 mg/m(2), 1.3 mg/m(2), and 1.6 mg/m(2)/ dose) once weekly with concurrent radiation in patients with histologically confirmed solid tumors and a radiographically appreciable lesion suitable for palliative radiation therapy. All patients received 40 Gy in 16 fractions to the target lesion. Dose-limiting toxicity was the primary endpoint, defined as any grade 4 hematologic toxicity, any grade ≥3 nonhematologic toxicity, or any toxicity requiring treatment to be delayed for ≥2 weeks. A total of 12 patients were enrolled. Primary sites included prostate (3 patients), head and neck (3 patients), uterus (1 patient), abdomen (1 patient), breast (1 patient), kidney (1 patient), lung (1 patient), and colon (1 patient). The maximum tolerated dose was not realized with a maximum dose of 1.6 mg/m(2). One case of dose-limiting toxicity was appreciated (grade 3 urosepsis) and felt to be unrelated to bortezomib. The most com...Continue Reading

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Citations

Aug 24, 2013·Radiation Oncology·Christopher D LaoBruce G Redman
Dec 5, 2012·Vaccine·Peter L SternMark H Einstein
Nov 17, 2011·Cancer Letters·Chao-Yuan HuangKuen-Feng Chen
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Mar 1, 2012·Expert Review of Molecular Diagnostics·Yu-Chang LiuJeng-Jong Hwang

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