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See Latest ArticlesPhase I clinical and pharmacokinetic study of the glucose-conjugated cytotoxic agent d-19575 (glufosfamide) in patients with solid tumors
Cancer Chemotherapy and Pharmacology, 06/04/09
Shimizu T et al. - In a study to determine the safety profile, pharmacokinetics, and antitumor activity of d-19575 in Japanese pts with advanced solid tumors, results show that d-19575 can be safely administered by infusion over 6 hr at 4500 mg/m2 every 3 wks. The safety profile and potential antitumor activity of d-19575 show that phase II studies of this drug are warranted.
Methods- Pts were treated with escalating doses of d-19575 administered by a 2-step (fast–slow) intravenous infusion over 6 hr every 3 wks.
- 13 pts received 43 treatment cycles (median 3) at d-19575 doses of 3200, 4500, or 6000 mg/m2.
- Hematologic toxicities and other side effects were generally mild.
- Maximum tolerated dose of d-19575 was 6000 mg/m2, at which 2 pts experienced dose-limiting toxicities (hypophosphatemia, hypokalemia, and metabolic acidosis each of grade 3).
- Pharmacokinetic analysis revealed a linear relation between the area under the concentration-vs-time curve (AUC) and dose.
- AUC values for isophosphoramide mustard were substantially greater than those achieved by bolus administration or continuous infusion of ifosfamide in conventional therapy.
- 1 pt with gallbladder cancer previously treated with cisplatin and gemcitabine achieved a partial response lasting for >5 mos, and 8 pts achieved disease stabilization.
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