Phase I Trial Of Cisplatin, Infusional 5-Fu And Irinotecan In Advanced Gastric Cancer.

2117 Background: There is not a standard chemotherapy treatment for advanced gastric cancer. Irinotecan/Cisplatin is one of the new combinations showing promising activity in this disease. Methods: This study aim to determine maximum tolerated dose (MTD) of a three drugs combination chemotherapy in patients with locally advanced non rescetable or metastatic gastric cancer. Other advanced solid tumors not previously treated for which the proposed chemotherapy is a reasonable therapeutic option could be included. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT). The recommended phase II dose is defined as the dose preceding the MTD A Phase I trial, started with: Infusional 5-FU: 14 days protacted infusion, days 1 and 22, fixed dose 200 mg/m2, weekly cisplatin: fixed dose 30 mg/m2, days 1,8,22 and 29. Weekly irinotecan days 1,8,22 and 29, 3 doses levels: 0: 55 mg/m2, 1: 60 mg/m2, 2: 65 mg/m2. Irinotecan dose escalation is allowed if 0/3 or 1/6 patients had limiting toxicity at previous dose level and at least three patients were treated for the entire treatment period in each level. DLT is defined as: G4 neutropenia and trombophenia for five days or more, fever or sepsis with neutropenia and other non-hematological grade 3–4 toxicity (excluding alopecia, anaemia and vomiting). Results: Three patients were included in first level, 2 males / 1 female (ages: 21,22,56). Two advanced gastric adenocarcinoma and one hepatocarcinoma Toxicity: diarrhea grade 2: one patient, asthenia grade 2: one patient, nausea grade 2: one patient. No MTD toxicity was found. Conclusions: In December 2003, the first level is completed without DLT. The study is ongoing and there is a patient included in second level. No significant financial relationships to disclose.