{"@type": "dcat:Dataset", "accessLevel": "public", "bureauCode": ["009:25"], "contactPoint": {"@type": "vcard:Contact", "fn": "NIH", "hasEmail": "mailto:info@nih.gov"}, "description": "Background\n          5-fluorouracil remains the standard therapy for patients with advanced/metastatic colorectal cancer. Pre-clinical studies have demonstrated the biological modulation of 5-fluorouracil by methotrexate and leucovorin. This phase II study was initiated to determine the activity and toxicity of sequential methotrexate \u2013 leucovorin and 5-fluorouracil chemotherapy in patients with advanced colorectal cancer.\n        \n        \n          Methods\n          Ninety-seven patients with metastatic colorectal cancer were enrolled onto the study. Methotrexate \u2013 30 mg/m2 was administered every 6 hours for 6 doses followed by a 2 hour infusion of LV \u2013 500 mg/m2. Midway through the leucovorin infusion, patients received 5-fluorouracil \u2013 600 mg/m2. This constituted a cycle of therapy and was repeated every 2 weeks until progression.\n        \n        \n          Results\n          The median age was 64 yrs (34\u201384) and the Eastern Cooperative Group Oncology performance score was 0 in 37%, 1 in 55% and 2 in 8% of patients. Partial and complete responses were seen in 31% of patients with a median duration of response of 6.4 months. The overall median survival was 13.0 months. The estimated 1-year survival was 53.7%. Grade III and IV toxic effects were modest and included mucositis, nausea and vomiting.\n          \n            Conclusions\n            This phase II study supports previously reported data demonstrating the modest clinical benefit of 5-FU modulation utilizing methotrexate and leucovorin in patients with metastatic colorectal cancer. Ongoing studies evaluating 5-fluorouracil modulation with more novel agents (Irinotecan and/or oxaliplatin) are in progress and may prove encouraging.", "distribution": [{"@type": "dcat:Distribution", "description": "Visit the original government dataset for complete information, documentation, and data access.", "downloadURL": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC113263/", "mediaType": "text/html", "title": "Official Government Data Source"}], "identifier": "https://healthdata.gov/api/views/cvzs-dwxw", "issued": "2025-07-14", "keyword": ["5-fluorouracil", "biochemical-modulation", "colorectal-cancer", "methotrexate-leucovorin", "nih"], "landingPage": "https://healthdata.gov/d/cvzs-dwxw", "modified": "2025-09-06", "programCode": ["009:032"], "publisher": {"@type": "org:Organization", "name": "National Institutes of Health"}, "theme": ["NIH"], "title": "Schedule-selective biochemical modulation of 5-fluorouracil in advanced colorectal cancer \u2013 a phase II study"}