PHASE-II TRIAL OF DIMETHYLTRIAZENOIMIDAZOLE CARBOXAMIDE IN PATIENTS WITH METASTATIC CARCINOID - A SOUTHWEST-ONCOLOGY-GROUP STUDY

Background. The use of chemotherapy in patients with metastatic carcin oid tumors has been of limited value, and investigation of new agents is necessary. Previous reports have suggested that dimethyltriazenoimi dazole carboxamide (DTIC) may have antitumor activity. Methods. A Phas e II trial to investigate the clinical response rate to DTIC in patien ts with metastatic carcinoid tumors was performed. DTIC was administer ed at low (650 mg/m(2)) or high (850 mg/m(2)) doses every 28 days. Res ults. Sixty-three patients were entered into the study, and 56 were ev aluable for toxicity and response. Toxicity was moderate, with the mos t common side effect being nausea and vomiting (88%). Nine patients (1 6%; 95% confidence interval, 8-28%) had partial responses, 5 of 25 rec eiving 850 mg/m(2) and 4 of 31 receiving 650 mg/m(2) of DTIC. Median s urvival time of all patients was 20 months. Conclusions. DTIC has mini mal activity in patients with metastatic carcinoid tumors.