Phase II study of dolastatin-10 as first-line treatment for advanced colorectal cancer

Dolastatin-10 is a potent inhibitor of microtubule assembly derived from the sea hare, which displayed significant antitumor activity in preclinical models. We conducted a phase II study of dolastatin-10 in patients with advanced colorectal cancer and no prior chemotherapy for metastatic disease, Fourteen patients received doses ranging from 300 mug/m(2) to 450 mug/m(2) as an intravenous push every 21 days. There were no major objective responses, Toxicity was mainly hematologic. with grade III or IV granulocytopenia occurring in 9 of 42 treatment courses. Other toxic effects were generally mild. Dolastatin-10 lacks clinically significant activity in advanced colorectal cancer when used in this dose and schedule.