Phase II trial of dimethyltriazenoimidazole carboxamide in patients with metastatic carcinoid

Abstract

Background. The use of chemotherapy in patients with metastatic carcinoid tumors has been of limited value, and investigation of new agents is necessary. Previous reports have suggested that dimethyltriazenoimidazole carboxamide (DTIC) may have antitumor activity. Methods. A Phase II trial to investigate the clinical response rate to DTIC in patients with metastatic carcinoid tumors was performed. DTIC was administered at low (650 mg/m²) or high (850 mg/m²) doses every 28 days. Results. Sixty-three patients were entered into the study, and 56 were evaluable for toxicity and response. Toxicity was moderate, with the most common side effect being nausea and vomiting (88%). Nine patients (16%; 95% confidence interval, 8–28%) had partial responses, 5 of 25 receiving 850 mg/m² and 4 of 31 receiving 650 mg/m² of DTIC. Median survival time of all patients was 20 months. Conclusions. DTIC has minimal activity in patients with metastatic carcinoid tumors. Cancer 1994; 73:1505–8.