PURPOSE: To evaluate the objective tumor response rate and safety profile of 
oxaliplatin when administered to patients with previously untreated metastatic 
colorectal adenocarcinoma.
PATIENTS AND METHODS: A total of 39 patients were entered onto this phase II 
trial. One patient was excluded for having had a second cancer, so the study was 
based on 38 patients. Patients were treated with oxaliplatin 130 mg/m2 as a 
2-hour infusion on day 1, every 21 days. Patients were assessed for response 
every three courses. All clinical and radiologic data were reviewed by an 
external panel of experts, with their assessment being considered definitive.
RESULTS: Nine partial responses (PRs) were observed (response rate, 24.3%; 95% 
confidence interval, 11.8% to 41.2%). The median duration of response was 216+ 
days. Fifteen patients (40.5%) had stable disease and 13 (35.2%) had progressive 
disease. The median progression-free survival time for all patients was 126+ 
days (range, 21 to 447+). The main toxicity was peripheral sensory neuropathy. 
Grade 3 neurotoxicity (National Cancer Institute common toxicity criteria 
[NCI-CTC]) was reported in 13%. Hematologic and gastrointestinal toxicities were 
mild. The incidence of grade 3 neutropenia was 5.2%, while that of grade 3 or 4 
thrombopenia was 7.9%. Vomiting (grade 3 or 4) occurred in 7.9% of patients and 
grade 3 diarrhea in 2.6%.
CONCLUSION: This phase II study provides clear evidence of the safety and 
efficacy of oxaliplatin monotherapy at this dose and schedule in patients with 
previously untreated metastatic colorectal carcinoma.