The RECIST criteria were used to evaluate clinical response [12], and all objective responses were confirmed by CT scans at least 4 weeks after the initial documentation of response. TTP and OS were calculated from the date of first chemotherapy cycle to the date of disease progression, death or last follow-up evaluation, respectively. Toxicity was assessed in each treatment cycle using the National Cancer Institute Common Toxicity Criteria (version 3.0). Peripheral sensitive neuropathy was graded according

to an oxaliplatin-specific scale as described previously [13]. Statistical Methods The primary end point of this study was to estimate the overall response rate of the regimen. Secondary end points were TTP, OS and safety. The Simon’s two-stage phase II design was used to determine the sample size [14]. An interim analysis was carried out when the first 18 assessable see more patients had been recruited. If more than 4 responses were observed, 15 additional patients were to be recruited; otherwise, the study was to be terminated. If more than 10 responses were observed in the 33 patients, the regimen was considered sufficiently active with a significance level of 5% and power of 80% to be submitted for further

evaluation. Seven additional patients were recruited in order to improve the statistical power. TTP and OS were analyzed according this website to the Kaplan-Meier method, and were updated to 31 December 2008. Results Patients over Characteristics From June 2006 to February 2008, 40 patients with metastatic gastric or GEJ cancer were enrolled by three oncologic Italian centres. All patients were evaluable for efficacy and toxicity. The pre-treatment characteristics of patients are listed in Table 1. None of the patients had previously received chemotherapy for advanced disease; six patients had received adjuvant chemotherapy without docetaxel or oxaliplatin several months before they entered this study (median,

12 months; range, 8–20 months). Table 1 Patient characteristics Characteristic No. of patients % Patients evaluable 40 100 Age, years        Median 65      Range 34–75   Sex        Male 24 60    Female 16 40 ECOG PS        0 6 15    1 27 67.5    2 7 17.5 Disease location        Gastric 30 75    GEJ 10 25 Histologic type        Diffuse 19 47.5    Intestinal 15 37.5    Unspecified 6 15 Previous adjuvant chemotherapy 6 15 Status of primary tumor        Unresected 28 70    Resected 12 30 Predominant site of disease        Liver 24 60    Peritoneum 8 20    Nodes 4 10    Lung 2 5    Bone 2 5 No. of metastatic sites        1 11 27.5    2 19 47.5    ≥ 3 10 25 Abbreviations: ECOG PS, Eastern Cooperative Oncology Group Performance Status; GEJ, gastroesophageal junction Efficacy Among 40 assessable patients, we observed two (5%) complete responses (CRs) and 17 (42.5%) partial responses (PRs), for an overall response rate of 47.5% (95% CI, 32–63).