Phase II randomized study of ISIS 3521 and ISIS 5132 in patients with locally advanced or metastatic colorectal cancer: a National Cancer Institute of Canada clinical trials group study.

摘要: Background: Because treatment of metastatic colon cancer is noncurative, new treatments are needed. This trial evaluated the antitumor effects two targeted anticancer agents: ( a ) ISIS 3521, an antisense inhibitor protein kinase C α; and b 5132, c-raf in patients untreated previously with recurrent or colorectal carcinoma. Patients Methods: All had adenocarcinoma measurable disease no prior chemotherapy for disease. were randomized to receive either 3521 5132 at dose 2 mg/kg/day as continuous i.v. infusion 21 28 days. Cycles repeated long progression was not seen, doses both agents modified according toxic effects. A two-arm study design used each arm considered independently. Steady-state blood levels molecules measured on days 8, 15, 22 first cycle therapy. Results: Thirty-seven eligible enrolled, 32 evaluable response (17 receiving 15 5132). No responses noted. Four stable disease, 5 stable. Conclusion: Neither nor 3521given schedule studied induced objective patients.