Phase II trial of edatrexate in patients with advanced pancreatic adenocarcinoma Journal Article


Authors: Casper, E. S.; Schwartz, G. K.; Johnson, B.; Kelsen, D. P.
Article Title: Phase II trial of edatrexate in patients with advanced pancreatic adenocarcinoma
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%. © 1992 Kluwer Academic Publishers.
Keywords: adult; cancer survival; clinical article; aged; advanced cancer; dose response; gastrointestinal hemorrhage; antineoplastic agents; pancreatic neoplasms; adenocarcinoma; pancreas; phase 2 clinical trial; blood toxicity; gastrointestinal symptom; drug administration schedule; drug effect; malaise; pancreas adenocarcinoma; sepsis; bile duct neoplasms; pancytopenia; phase ii; aminopterin; intravenous drug administration; middle age; edatrexate; human; male; female; priority journal; article; support, u.s. gov't, p.h.s.
Journal Title: Investigational New Drugs
Volume: 10
Issue: 4
ISSN: 0167-6997
Publisher: Springer  
Date Published: 1992-11-01
Start Page: 313
End Page: 316
Language: English
DOI: 10.1007/bf00944187
PUBMED: 1487406
PROVIDER: scopus
DOI/URL:
Notes: Article -- Source: Scopus
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  1. Gary Schwartz
    385 Schwartz
  2. David P Kelsen
    537 Kelsen
  3. Ephraim S Casper
    108 Casper