A phase II trial of PALA + dipyridamole in patients with advanced soft-tissue sarcoma Journal Article


Authors: Casper, E. S.; Baselga, J.; Smart, T. B.; Magill, G. B.; Markman, M.; Ranhosky, A.
Article Title: A phase II trial of PALA + dipyridamole in patients with advanced soft-tissue sarcoma
Abstract: A total of 21 patients with advanced soft tissue sarcoma enrolled in a phase II trial of 3.5 g/m2N-phosphonacetyl-l-aspartate (PALA) given intravenously every 3 weeks plus 50 mg/m2 dipyridamole (Persantine) given orally every 6 h. Dipyridamole administration was initiated 1 week before the first dose of PALA. Peak and trough plasma concentrations of dipyridamole were measured before and after the first dose of PALA in 14 patients. In all, 19 patients were evaluable for therapeutic response. One subject experienced partial regression of a pulmonary metastasis; no other major response was observed. Diarrhea was the most prominent toxicity; in one patient it was life-threatening and was associated with a severe rash. On the day preceding PALA administration, the median peak plasma concentration of dipyridamole was 2,208 ng/ml and the median trough value was 904 ng/ml. Similar values were obtained on the day of PALA administration. Although the levels achieved were similar to those required to modulate the activity of PALA in preclinical systems, the therapeutic results obtained in the present study were not superior to those reported for PALA alone in previously treated patients with soft-tissue sarcoma. © 1991 Springer-Verlag.
Keywords: adult; clinical article; aged; diarrhea; antineoplastic agents; phase 2 clinical trial; bone marrow suppression; sarcoma; drug therapy, combination; soft tissue sarcoma; aspartic acid; soft tissue neoplasms; intravenous drug administration; phosphonoacetic acid; middle age; drug evaluation; dipyridamole; sparfosic acid; human; male; female; priority journal; article; support, non-u.s. gov't; support, u.s. gov't, p.h.s.
Journal Title: Cancer Chemotherapy and Pharmacology
Volume: 28
Issue: 1
ISSN: 0344-5704
Publisher: Springer  
Date Published: 1991-01-01
Start Page: 51
End Page: 54
Language: English
DOI: 10.1007/bf00684956
PUBMED: 2040033
PROVIDER: scopus
DOI/URL:
Notes: Article -- Export Date: 27 September 2019 -- Source: Scopus
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MSK Authors
  1. Ephraim S Casper
    87 Casper
  2. Jose T Baselga
    474 Baselga
  3. Maurie Markman
    81 Markman
  4. Gordon B. Magill
    12 Magill