biostudies-literatureWang FFundamental Research Funds for the Central UniversitiesMedical Science and Technology Foundation of Guangdong ProvinceScience and Technology Program of GuangzhouNational Natural Science Foundation of ChinaNatural Science Foundation of Guangdong ProvincePearl River Nova Program of GuangzhouNational Key Research and Development Program of China460https://www.ebi.ac.uk/biostudies/studies/S-EPMC6524297biostudies-literatureUnknown19(1)<h4>Background</h4>Preclinical studies suggest synergistic effectiveness of ascorbic acid (AA, vitamin C) and cytotoxic agents in gastrointestinal malignancies. This phase 1 study aimed to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AA combined with mFOLFOX6 or FOLFIRI regimens in patients with metastatic colorectal cancer (mCRC) or gastric cancer (mGC).<h4>Methods</h4>In the dose-escalation phase, patients received AA (0.2-1.5 g/kg, 3-h infusion, once daily, days 1-3) with mFOLFOX6 or FOLFIRI in a 14-day cycle until the MTD was reached. In the speed-expansion phase, AA was administered at the MTD or at 1.5 g/kg if the MTD was not reached at a fixed rate of 0.6, 0.8 or 1 g/min. Pharmacokinetics and preliminary efficacy were also assessed.<h4>Results</hBMC cancerPhase I study of high-dose ascorbic acid with mFOLFOX6 or FOLFIRI in patients with metastatic colorectal cancer or gastric cancer.PMC6524297818720112017YFC13089002014A03031201514ykpy402015B02023200820161001006815570006Chen SZLv ZDHe MMWang FShi SMJin YRen CWang DSLi YHLi SXu RHWang ZQBi BTWang ZXWang FHHu JJfalsePhase I study of high-dose ascorbic acid with mFOLFOX6 or FOLFIRI in patients with metastatic colorectal cancer or gastric cancer.<h4>Background</h4>Preclinical studies suggest synergistic effectiveness of ascorbic acid (AA, vitamin C) and cytotoxic agents in gastrointestinal malignancies. This phase 1 study aimed to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AA combined with mFOLFOX6 or FOLFIRI regimens in patients with metastatic colorectal cancer (mCRC) or gastric cancer (mGC).<h4>Methods</h4>In the dose-escalation phase, patients received AA (0.2-1.5 g/kg, 3-h infusion, once daily, days 1-3) with mFOLFOX6 or FOLFIRI in a 14-day cycle until the MTD was reached. In the speed-expansion phase, AA was administered at the MTD or at 1.5 g/kg if the MTD was not reached at a fixed rate of 0.6, 0.8 or 1 g/min. Pharmacokinetics and preliminary efficacy were also assessed.<h4>Results</h2019-01-01T00:00:00Z2019 May2026-05-07T13:55:49.589Z2019-06-06T23:16:52ZS-EPMC65242973109693710.1186/s12885-019-5696-z