Clinical and pharmacological study of intrahepatic artery infusion of thiotepa.

Twenty patients with primary or metastatic liver cancer were treated on a clinical and pharmacological study with intrahepatic artery infusion of Thiotepa. Toxicity was tolerable and included nausea and fatigue. Uncommon side effects were myelosuppression, abdominal pain and anemia. 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 revealed an extraction ratio similar to that reported for cisplatin. The data suggest increased hepatic clearance for Thiotepa either by binding or metabolism.