Phase I Study to Determine the Starting Dose for Estimating the Individualized Maximum Repeatable Dose in Tumor Dormancy Therapy with Weekly Paclitaxel for Recurrent and Metastatic Head and Neck Cancer

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  • 再発・転移頭頸部癌症例に対するパクリタキセル週1回投与による休眠療法
  • 再発・転移頭頸部癌症例に対するパクリタキセル週1回投与による休眠療法 : 個別化最大継続可能量設定を目的とした開始用量決定のための第1相試験
  • サイハツ ・ テンイトウ ケイブガン ショウレイ ニ タイスル パクリタキセル シュウ 1カイ トウヨ ニ ヨル キュウミン リョウホウ : コベツカ サイダイ ケイゾク カノウリョウ セッテイ オ モクテキ ト シタ カイシ ヨウリョウ ケッテイ ノ タメ ノ ダイ1ソウ シケン
  • ―個別化最大継続可能量設定を目的とした開始用量決定のための第1相試験―

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Abstract

<p>Introduction: Individualized maximum repeatable dose (iMRD) is the maximum dose at which a drug can be repeated in an individual to maintain the toxicity grade at 1 or lower. In this phase I study, the starting dose to estimate the iMRD in weekly paclitaxel treatment for recurrent and/or head and neck cancer patients was determined.</p><p>Patients and Methods: Patients were enrolled according to the modified Fibonacci method. Six patients were enrolled at the starting dose of level 0 (60 mg/m2). Weekly dose adjustments were made to maintain the toxicity at grade 1 or lower. The iMRD was estimated after the 6th infusion.</p><p>Results: One patient developed grade 3 neutropenia, while another developed grade 2 neutropenia that did not resolve within 2 weeks. The iMRD could be estimated in four of the six enrolled patients. The starting dose was determined to be level −1 (50 mg/m2).</p><p>Conclusion: A phase II study of weekly paclitaxel at the aforementioned starting dose to detect iMRD has been planned. In patients for whom the iMRD can be detected, tumor dormancy therapy with weekly paclitaxel can be continued without compromising the quality of life.</p>

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