Phase I/II randomized trial of intrahepatic arterial infusion chemotherapy with cisplatin and chemoembolization with cisplatin and polyvinyl sponge in patients with ocular melanoma metastatic to the liver.

Ocular melanoma has a unique metastatic predilection for the liver and is refractory to most forms of therapy. The dual blood supply of the liver with differential perfusion of metastatic lesions and normal hepatocytes by the hepatic artery and portal vein, respectively, has led to the evaluation of intrahepatic chemotherapy and chemoembolization in this disease. Despite suggestion of efficacy in phase II trials, this therapy has not been systematically evaluated. We conducted a randomized phase I/II trial evaluating escalating doses of intrahepatic chemotherapy with cisplatin with or without polyvinyl sponge (PVS) in 19 patients with ocular melanoma and liver metastases. The cisplatin dose was initiated at 100 mg/m and was increased in 25% increments. Patients were randomized to receive cisplatin alone or cisplatin plus PVS. Seven patients were treated with intrahepatic cisplatin at 100 mg/m: four with PVS, and three without. The dose was escalated to 125 mg/m with or without PVS in the remaining 12 patients. The maximum tolerated dose for intra-hepatic cisplatin was determined to be 125 mg/m with or without PVS. The overall response rate was 16%. Dose-limiting toxicities included renal, hepatic and haematological effects. This therapy produces a modest response rate in patients with ocular melanoma and liver metastases.

RCT Entities:   Population Interventions Outcomes