{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Wang F"],"funding":["Fundamental Research Funds for the Central Universities","Medical Science and Technology Foundation of Guangdong Province","Science and Technology Program of Guangzhou","National Natural Science Foundation of China","Natural Science Foundation of Guangdong Province","Pearl River Nova Program of Guangzhou","National Key Research and Development Program of China"],"pagination":["460"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC6524297"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["19(1)"],"pubmed_abstract":["<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</h"],"journal":["BMC cancer"],"pubmed_title":["Phase I study of high-dose ascorbic acid with mFOLFOX6 or FOLFIRI in patients with metastatic colorectal cancer or gastric cancer."],"pmcid":["PMC6524297"],"funding_grant_id":["81872011","2017YFC1308900","2014A030312015","14ykpy40","2015B020232008","201610010068","15570006"],"pubmed_authors":["Chen SZ","Lv ZD","He MM","Wang F","Shi SM","Jin Y","Ren C","Wang DS","Li YH","Li S","Xu RH","Wang ZQ","Bi BT","Wang ZX","Wang FH","Hu JJ"],"additional_accession":[]},"is_claimable":false,"name":"Phase I study of high-dose ascorbic acid with mFOLFOX6 or FOLFIRI in patients with metastatic colorectal cancer or gastric cancer.","description":"<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</h","dates":{"release":"2019-01-01T00:00:00Z","publication":"2019 May","modification":"2026-05-07T13:55:49.589Z","creation":"2019-06-06T23:16:52Z"},"accession":"S-EPMC6524297","cross_references":{"pubmed":["31096937"],"doi":["10.1186/s12885-019-5696-z"]}}