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A phase I and clinical pharmacology study of intravenously administered carminomycin in cancer patients in the United States.

Abstract
Carminomycin (CMN) was administered i.v. to 44 patients with a variety of nonhematological cancers every 4 weeks at doses of 15, 20, 22.5, and 25 mg/sq m. Granulocytopenia was the dose-limiting toxicity. The median granulocyte count for previously untreated patients receiving 22.5 mg/sq m was 0.962 cells/microliters, and for previously treated patients receiving 20 mg/sq m it was 0.420 cell/microliters. Moderate to severe phlebitis was associated with drug administration in 50% of cases. Nausea, vomiting, and alopecia were mild. Three of nine patients who received a total CMN dose of greater than or equal to 100 mg/sq m (mean, 132 mg/sq m) developed unexplained decreases in radionuclide cardiac ejection fraction, with one patient developing decreased QRS amplitude and congestive heart failure at a total dose of 160 mg/sq m. CMN is rapidly metabolized to carminomycinol. The elimination half-lives of CMN and carminomycinol are 6 to 10 and 50 hr, respectively. CMN was found to be a more potent inhibitor of human granulocyte-macrophage colony-forming units than was carminomycinol. Objective partial responses were seen in two of seven previously untreated patients with non-small cell lung cancer and one of three patients with squamous cell carcinoma of the head and neck previously untreated with chemotherapy.
AuthorsR L Comis, B F Issell, K Pittman, S J Ginsberg, A Rudolph, J C Aust, S M DiFino, R W Tinsley, B J Poiesz, S T Crooke
JournalCancer research (Cancer Res) Vol. 42 Issue 7 Pg. 2944-8 (Jul 1982) ISSN: 0008-5472 [Print] United States
PMID7083181 (Publication Type: Journal Article, Research Support, U.S. Gov't, P.H.S.)
Chemical References
  • dihydrocarminomycin
  • Carubicin
  • Daunorubicin
Topics
  • Adult
  • Aged
  • Agranulocytosis (chemically induced)
  • Carubicin (administration & dosage, adverse effects, analogs & derivatives, blood, pharmacology)
  • Colony-Forming Units Assay
  • Daunorubicin (analogs & derivatives)
  • Drug Evaluation
  • Female
  • Heart Diseases (chemically induced)
  • Humans
  • Infusions, Parenteral
  • Male
  • Middle Aged
  • Neoplasms (blood, drug therapy)

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