Abstract
We conducted a phase II evaluation of edatrexate in 17 previously untreated patients with advanced adenocarcinoma of the pancreas; 14 patients had at least one month of therapy. The initial dose was 80 mg/m2iv. Treatment was administered weekly for 5 weeks, then every other week. Toxicity was generally mild. The median WBC nadir was 5.4 (range 0.6–7.4)×103/μl, and the median platelet nadir was 164.0 (range 62.0–341.0)×103/μl. One patient died with sepsis and gastrointestinal bleeding associated with pancytopenia. Five patients had a mild rash. Nausea occurred in 6 patients, including 3 who had vomiting. In addition, 11 patients complained of vague malaise which seemed to begin within 24–48 hours after administration of edatrexate, and lasted for 2 to 3 days, resolving within 6 days of drug administration. Median survival was 85 days. Although 5 patients had stable disease, including one with relief of pain, no major responses were seen, excluding, with 95% confidence, a response rate in excess of 20%.
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Casper, E.S., Schwartz, G.K., Johnson, B. et al. Phase II trial of edatrexate in patients with advanced pancreatic adenocarcinoma. Invest New Drugs 10, 313–316 (1992). https://doi.org/10.1007/BF00944187
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DOI: https://doi.org/10.1007/BF00944187