CLINICAL AND PHARMACOLOGICAL STUDY OF INTRAHEPATIC ARTERY INFUSION OFTHIOTEPA

Twenty patients with primary or metastatic liver cancer were treated o n a clinical and pharmacological study with intrahepatic artery infusi on of Thiotepa. Toxicity was tolerable and included nausea and fatigue . Uncommon side effects were myelosuppression, abdominal pain and anem ia. One patient with gallbladder cancer had a partial response for 11 (+) months. Recommended dose of Thiotepa for future Phase II clinical trials is 1.0 mg/kg. Pharmacokinetics of intrahepatic Thiotepa reveale d an extraction ratio similar to that reported for cisplatin. The data suggest increased hepatic clearance for Thiotepa either by binding or metabolism