DOXIL AND CISPLATIN IN PATIENTS WITH ADVANCED SOLID TUMORS

$21,006M01FY2000RRNIH

New York University School Of Medicine, New York NY

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Abstract

Liposomal encapsulation of doxorubicin may reduce doxorubicin+s toxicity while improving its specificity. DOXIL is a doxorubicin formulation in which the drug is encapsulated in liposomes that can avoid uptake by the reticuloendothelial system. In recent clinical studies, DOXIL plus cisplatin has been effective in treating ovarian cancer. This study proposes that this combination may be attractive for a number of other malignancies. Subjects will be screened prior to therapy with laboratory work and appropriate radiologic scans. Subjects will begin therapy at 30 mg/m2 of DOXIL and 30 mg/m2 of cisplatin every 3 weeks. If no or minimal toxicity is observed, the cisplatin dose in the next cohort of patients will be escalated to 40 mg/m2. Escalation will continue until the maximally tolerated dose is reached. Subjects will be closely monitored by the study staff with blood tests and radiologic scans to assess response to therapy.

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