Randomized, Placebo-Controlled, Phase III Study of Oxaliplatin, Fluorouracil, and Leucovorin With or Without PTK787/ZK 222584 in Patients With Previously Treated Metastatic Colorectal Adenocarcinoma

摘要: Purpose Treatment options for patients with previously treated metastatic colorectal cancer (mCRC) are limited, and treatments differing mechanisms of action needed. PTK787/ZK 222584 (PTK/ZK) is a novel oral angiogenesis inhibitor therapeutic potential the treatment solid tumors. Methods Patients (N = 855) were randomly assigned to PTK/ZK or placebo once daily in combination oxaliplatin, fluorouracil, leucovorin (FOLFOX4). Stratification factors included WHO performance status (PS; 0 v 1 2) lactate dehydrogenase ([LDH] ≤ 1.5× upper limit normal [ULN] > 1.5 × ULN). was given until disease progression unacceptable toxicity. The primary end point overall survival (OS); secondary points progression-free (PFS), safety, tolerability, pharmacokinetics PTK/ZK. Results No statistically significant differences seen between groups comparison OS. With placebo, res...