Phase III Double-Blind Placebo-Controlled Study of Farnesyl Transferase Inhibitor R115777 in Patients With Refractory Advanced Colorectal Cancer

• DOI: 10.1200/jco.2004.10.037
• Publication Date: 2004-09-30T00:18:26Z
• Authors: S. Rao; D. Cunningham; A. de Gramont; W. Scheithauer; M. Smakal; Y. Humblet; G. Kourteva; T. Iveson; T. Andre; J. Dostalova; A. Illes; R. Belly; J.J. Perez-Ruixo; Y.C. Park; P.A. Palmer
• Keywords: Clinical endpoint; Refractory (planetary science)

To determine whether R115777 improves survival in patients with refractory advanced colorectal cancer (CRC) a multicenter, double-blind, prospective randomized study.Three hundred sixty-eight were randomly assigned to (300 mg twice daily) orally for 21 days every 28 or placebo 2:1 ratio. All received best supportive care. The primary end point was overall survival; secondary points progression free survival, tumor response, toxicity, and quality of life.The two treatment groups well balanced baseline demographics, including previous chemotherapy CRC. median 174 (95% CI, 157 198 days), 185 158 238 days) those receiving (P =.376). One patient achieved partial response the arm. Stable disease (> 3 months) observed 24.3% group compared 12.8% This did not translate into statistically significant increase progression-free survival. Overall, tolerated. There an increased incidence reversible myelosuppression (neutropenia, thrombocytopenia), rash, grade 1 2 diarrhea no difference life between arms.Single agent R115777, given at this dose schedule, has acceptable toxicity profile, but does improve care alone