Phase I clinical trial of fludarabine phosphate (F-ara-AMP) Journal Article


Authors: Casper, E. S.; Mittelman, A.; Kelson, D.; Young, C. W.
Article Title: Phase I clinical trial of fludarabine phosphate (F-ara-AMP)
Abstract: F-Ara-AMP (fludarabine phosphate) is an adenosine analogue that is resistant to deamination; it is a more potent cytotoxic compound than ara-A in experimental tumor systems. F-Ara-AMP was given by continuous IV infusion over 5 days once every 4 weeks to 27 evaluable adult patients with advanced cancer. The median Karnofsky performance status was 70% (range 50%-90%), and the median age was 58 years (range 41-74). In addition to adequate blood counts, a creatinine clearance of at least 60 ml/min was required. The initial dose level was 35 mg/m2/day. Dose-limiting myelosuppression was seen in the first patient. Subsequent patients were treated at lower doses. Myelosuppression was the only major toxicity. Leukopenia was generally more prominent than thrombocytopenia, but 2 patients experienced prolonged thrombocytopenia which prevented further therapy. Nausea was minimal, and neither renal nor neurologic toxicity was encountered. In patients with good renal function a dose of 25 mg/m2/day can be safely administered. However, because of apparent cumulative myelosuppressive effects a lower dose is more appropriate for patients who have had extensive prior chemotherapy or radiotherapy. © 1985 Springer-Verlag.
Keywords: adult; cancer chemotherapy; clinical article; aged; fludarabine; fatigue; diarrhea; drug efficacy; comparative study; neoplasms; nephrotoxicity; bone marrow; leukopenia; nausea; thrombocytopenia; vomiting; gastrointestinal toxicity; narcotic analgesic agent; kidney; drug accumulation; drug dose; phase 1 clinical trial; drug therapy; adverse drug reaction; therapy; intravenous drug administration; middle age; bone marrow depression; drug evaluation; intoxication; fludarabine phosphate; vidarabine phosphate; dose kidney function relation; human; male; female; priority journal; visual hallucination; support, u.s. gov't, p.h.s.; blood and hemopoietic system; arabinonucleotides
Journal Title: Cancer Chemotherapy and Pharmacology
Volume: 15
Issue: 3
ISSN: 0344-5704
Publisher: Springer  
Date Published: 1985-10-01
Start Page: 233
End Page: 235
Language: English
DOI: 10.1007/bf00263892
PROVIDER: scopus
PUBMED: 2414021
DOI/URL:
Notes: Article -- Export Date: 26 October 2021 -- Source: Scopus
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  1. Ephraim S Casper
    108 Casper
  2. Charles W Young
    82 Young