Details

Autor(en) / Beteiligte

• RATAIN, M. J
• SKOOG, L. A
• O'BRIEN, S. M
• COOPER, N
• SCHILSKY, R. L
• VOGELZANG, N. J
• GERBER, M
• NARANG, P. K
• NICOL, S. J

Titel

Phase I study of 3'-deamino-3'-(2-methoxy-4-morpholinyl)doxorubicin (FCE 23762, PNU 152243) administered on a daily x3 schedule

Ist Teil von

• Annals of oncology, 1997-08, Vol.8 (8), p.807-809

Ort / Verlag

Oxford: Oxford University Press

Erscheinungsjahr

1997

Quelle

MEDLINE

Beschreibungen/Notizen

• 3'-Deamino-3'-(2-methoxy-4-morpholinyl)doxorubicin (FCE 23762, PNU 152243) is a highly lipophilic doxorubicin derivative which possesses potent in vitro and in vivo antitumor activity. Previous phase I studies had been conducted using a single bolus every 28 days. We conducted a phase I study of FCE 23762 on a daily x3 every 28 days schedule. Thirty patients received 68 cycles of therapy at 5 dose levels (200-600 micrograms/m2/d). Prolonged neutropenia and thrombocytopenia were the dose-limiting toxicities. Other nonhematological toxicities included nausea and vomiting, anorexia, fatigue and transient elevations of serum creatinine and hepatic transaminases. No cardiac toxicity was demonstrated. There were no partial or complete antitumor responses. The recommended phase II dose using the schedule defined in this study is 500 micrograms/m2/dx3.