PHASE-I CLINICAL-STUDY OF QUELAMYCIN

  • 1 January 1978
    • journal article
    • research article
    • Vol. 62  (10) , 1527-1534
Abstract
A phase I clinical study was done with quelamycin, a recently synthesized triferric derivative of adriamycin. Good-risk patients were studied, 19 with non-small cell carcinoma of the lung and 2 with metastatic sarcoma. Acute toxicity occurred in all patients and consisted of high fever, flushing, hypertension, generalized body aches, tremors and confusion, which lasted 3-6 h. Potentially dangerous cardiotoxicity occurred in 8 patients who had previous minor rhythm disturbances, and was characterized by tachycardia, atrial extrasystoles, atrial fibrillation and branch block which lasted 6-14 h. The dose-limiting hematologic toxicity occurred at 125 mg/m2 i.v. single-dose. Limited pharmacokinetic studies suggested considerable differences from adriamycin: enhanced urinary excretion, penetration into the brain (CSF) and slow plasma decay. Objective responses were observed in 3 of 19 patients with lung cancer and in 1 patient with metastatic osteogenic sarcoma resistant to adriamycin therapy. The acute generalized toxicity and the immediate cardiotoxicity found in the presently used schedule were excessive.

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