Metastatic colorectal carcinoma. A prospective randomized trial of Methyl-CCNU, 5-Fluorouracil (5-FU) and vincristine (MOF) versus MOF plus streptozotocin (MOF-Strep).

A prospective randomized trial evaluated semustine (Methyl CCNU) 5-Fluorouracil (5-FU) and vincristine (MOF) versus MOF plus streptozotocin (MOF-Strep) in 75 patients with advanced, measurable colorectal carcinoma. The complete and partial remission rate with MOF-Strep was significantly better, 34 versus 5% with MOF (P = 0.003). Gastrointestinal toxicity was increased with the addition of streptozotocin. Initial patient characteristics such as age, sex, performance status, time from diagnosis to metastatic disease, site of metastatic disease, and most initial laboratory values were not predictive of response. However, certain initial laboratory values (lactic dehydrogenace and leukocyte count) and one tumor site pulmonary metastases did influence survival regardless of response.

RCT Entities:   Population Interventions Outcomes