E6 MIX (MITOMYCIN-C, IRINOTECAN, XELODA) REGIMEN IN THE TREATMENT OF ADVANCED GASTRIC CANCER (AGC). A PHASE I STUDY OF THE GRUPPO ONCOLOGICO DELL’ITALIA MERIDIONALE (GOIM) F. Giuliani1, R. Romano2, S. Romito3, M. Di Bisceglie1, E. Maiello1, G. Vinciarelli1, R. Mallamaci1, L. Manzione2, G. Colucci1 1Medical and Experimental Oncology Unit, Oncology Institute-Bari, Italy; 2Medical Oncology Unit, S. Carlo Hospital-Potenza, Italy; 3Medical Oncology Unit, Cardarelli Hospital-Campobasso, Italy Introduction: In our previous experience the combination of M and I is active in pretreated AGC pts. Capecitabine (X) is more active than FA-FU in pts with ACC and is synergic when combined with I. Taking into account these data the GOIM started a phase I study to determine the DLTs and the MTD of the MIX combination in AGC pts. Material and methods: M and I were administered at fixed doses as follows: M at 8 mg/mq on day 1, I at 150 mg/mq on day 1 and 15 while X at escalated doses starting from 1250 mg/mq p.o. and increasing of 250 mg/mq at each dose level from the 2nd to the 15th day. The cycles were repeated every 4 weeks. DLTs was defined as NCI G3-4 febrile neutropenia or G4 thrombocytopenia or any >G3 non-haematologic toxicities. The MTD was defined as the dose level immediately below that at which the DLTs were observed in 2/3 patients. Results: 9 pts (M/F: 5/4) with median PS 1, were treated at the following 3 dose-levels: Conclusions: The DLT of the MIX combination was neutropenia. The recommended dose for phase II(III studies is 8, 150, and 1500 mg/mq for the three drugs, respectively. A phase II study is ongoing..
Mix (mitomycin-C, irinotecan, xeloda) regimen in the treatment of advanced gastric cancer (AGC). A phase I study of the gruppo oncologico dell'italia meridionale (GOIM)
MALLAMACI, Rosanna;
2005-01-01
Abstract
E6 MIX (MITOMYCIN-C, IRINOTECAN, XELODA) REGIMEN IN THE TREATMENT OF ADVANCED GASTRIC CANCER (AGC). A PHASE I STUDY OF THE GRUPPO ONCOLOGICO DELL’ITALIA MERIDIONALE (GOIM) F. Giuliani1, R. Romano2, S. Romito3, M. Di Bisceglie1, E. Maiello1, G. Vinciarelli1, R. Mallamaci1, L. Manzione2, G. Colucci1 1Medical and Experimental Oncology Unit, Oncology Institute-Bari, Italy; 2Medical Oncology Unit, S. Carlo Hospital-Potenza, Italy; 3Medical Oncology Unit, Cardarelli Hospital-Campobasso, Italy Introduction: In our previous experience the combination of M and I is active in pretreated AGC pts. Capecitabine (X) is more active than FA-FU in pts with ACC and is synergic when combined with I. Taking into account these data the GOIM started a phase I study to determine the DLTs and the MTD of the MIX combination in AGC pts. Material and methods: M and I were administered at fixed doses as follows: M at 8 mg/mq on day 1, I at 150 mg/mq on day 1 and 15 while X at escalated doses starting from 1250 mg/mq p.o. and increasing of 250 mg/mq at each dose level from the 2nd to the 15th day. The cycles were repeated every 4 weeks. DLTs was defined as NCI G3-4 febrile neutropenia or G4 thrombocytopenia or any >G3 non-haematologic toxicities. The MTD was defined as the dose level immediately below that at which the DLTs were observed in 2/3 patients. Results: 9 pts (M/F: 5/4) with median PS 1, were treated at the following 3 dose-levels: Conclusions: The DLT of the MIX combination was neutropenia. The recommended dose for phase II(III studies is 8, 150, and 1500 mg/mq for the three drugs, respectively. A phase II study is ongoing..I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
