A Phase I–II dose escalation study of fixed-dose rate gemcitabine, oxaliplatin and capecitabine every two weeks in advanced cholangiocarcinomas

References

• Park J, Kim M, Kim J, Lee J. Survival time and its prognostic factors in advanced unresected cholangiocarcinoma without chemoradiation. J Clin Oncol 2009;27(Suppl; Abstract e15681).
   Google Scholar
• Eckel F, Schmid RM. Chemotherapy in advanced biliary tract carcinoma: A pooled analysis of clinical trials. Br J Cancer 2007;96:896–902.
   PubMed Web of Science ®Google Scholar
• Kornek GV, Schuell B, Laengle F, Gruenberger T, Penz M, Karall K, . Mitomycin C in combination with capecitabine or biweekly high-dose gemcitabine in patients with advanced biliary tract cancer: A randomised phase II trial. Ann Oncol 2004;15:478–83.
   PubMed Web of Science ®Google Scholar
• Cho JY, Nam JS, Park MS, Yu JS, Paik YH, Lee SJ, . A Phase II study of capecitabine combined with gemcitabine in patients with advanced gallbladder carcinoma. Yonsei Med J 2005;46:526–31.
   PubMedGoogle Scholar
• Cho JY, Paik YH, Chang YS, Lee SJ, Lee DK, Song SY, . Capecitabine combined with gemcitabine (CapGem) as first-line treatment in patients with advanced/metastatic biliary tract carcinoma. Cancer 2005;104:2753–8.
   PubMed Web of Science ®Google Scholar
• Riechelmann RP, Townsley CA, Chin SN, Pond GR, Knox JJ. Expanded phase II trial of gemcitabine and capecitabine for advanced biliary cancer. Cancer 2007;110:1307–12.
   PubMed Web of Science ®Google Scholar
• Park SH, Park YH, Lee JN, Bang SM, Cho EK, Shin DB, . Phase II study of epirubicin, cisplatin, and capecitabine for advanced biliary tract adenocarcinoma. Cancer 2006;106:361–5.
   PubMed Web of Science ®Google Scholar
• Hong YS, Lee J, Lee SC, Hwang IG, Choi SH, Heo JS, . Phase II study of capecitabine and cisplatin in previously untreated advanced biliary tract cancer. Cancer Chemother Pharmacol 2007;60:321–8.
   PubMedGoogle Scholar
• Iyer RV, Gibbs J, Kuvshinoff B, Fakih M, Kepner J, Soehnlein N, . A phase II study of gemcitabine and capecitabine in advanced cholangiocarcinoma and carcinoma of the gallbladder: A single-institution prospective study. Ann Surg Oncol 2007;14:3202–9.
   PubMedGoogle Scholar
• Koeberle D, Saletti P, Borner M, Gerber D, Dietrich D, Caspar CB, . Patient-reported outcomes of patients with advanced biliary tract cancers receiving gemcitabine plus capecitabine: A multicenter, phase II trial of the Swiss Group for Clinical Cancer Research. J Clin Oncol 2008;26:3702–8.
   PubMed Web of Science ®Google Scholar
• Nehls O, Oettle H, Hartmann JT, Hofheinz RD, Hass HG, Horger MS, . Capecitabine plus oxaliplatin as first-line treatment in patients with advanced biliary system adenocarcinoma: A prospective multicentre phase II trial. Br J Cancer 2008;98:309–15.
   PubMed Web of Science ®Google Scholar
• Andre T, Tournigand C, Rosmorduc O, Provent S, Maindrault-Goebel F, Avenin D, . Gemcitabine combined with oxaliplatin (GEMOX) in advanced biliary tract adenocarcinoma: A GERCOR study. Ann Oncol 2004;15:1339–43.
   PubMed Web of Science ®Google Scholar
• Tempero M, Plunkett W, Ruiz VH, Hainsworth J, Hochster H, Lenzi R, . Randomized phase II comparison of dose-intense gemcitabine: Thirty-minute infusion and fixed dose rate infusion in patients with pancreatic adenocarcinoma. J Clin Oncol 2003;21:3402–8.
   PubMed Web of Science ®Google Scholar
• Goetz MP, Erlichman C, Windebank AJ, Reid JM, Sloan JA, Atherton P, . Phase I and pharmacokinetic study of two different schedules of oxaliplatin, irinotecan, Fluorouracil, and leucovorin in patients with solid tumors. J Clin Oncol 2003;21:3761–9.
   PubMed Web of Science ®Google Scholar
• Goel S, Bulgaru A, Hochster H, Wadler S, Zamboni W, Egorin M, . Phase I clinical study of infusional 5-fluorouracil with oxaliplatin and gemcitabine (FOG regimen) in patients with solid tumors. Ann Oncol 2003;14:1682–7.
   PubMedGoogle Scholar
• Ychou M, Conroy T, Seitz JF, Gourgou S, Hua A, Mery-Mignard D, . An open phase I study assessing the feasibility of the triple combination: Oxaliplatin plus irinotecan plus leucovorin/5-fluorouracil every 2 weeks in patients with advanced solid tumors. Ann Oncol 2003;14:481–9.
   PubMed Web of Science ®Google Scholar
• Souglakos J, Mavroudis D, Kakolyris S, Kourousis C, Vardakis N, Androulakis N, . Triplet combination with irinotecan plus oxaliplatin plus continuous-infusion fluorouracil and leucovorin as first-line treatment in metastatic colorectal cancer: A multicenter phase II trial. J Clin Oncol 2002;20:2651–7.
   PubMed Web of Science ®Google Scholar
• Correale P, Messinese S, Marsili S, Ceciarini F, Pozzessere D, Petrioli R, . A novel biweekly pancreatic cancer treatment schedule with gemcitabine, 5-fluorouracil and folinic acid. Br J Cancer 2003;89:239–42.
   PubMed Web of Science ®Google Scholar
• Scheithauer W, Kornek GV, Raderer M, Schull B, Schmid K, Kovats E, . Randomized multicenter phase II trial of two different schedules of capecitabine plus oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 2003;21:1307–12.
   PubMed Web of Science ®Google Scholar
• Khan SA, Thomas HC, Davidson BR, Taylor-Robinson SD. Cholangiocarcinoma. Lancet 2005;366:1303–14.
   PubMed Web of Science ®Google Scholar
• Khan SA, Davidson BR, Goldin R, Pereira SP, Rosenberg WM, Taylor-Robinson SD, . Guidelines for the diagnosis and treatment of cholangiocarcinoma: Consensus document. Gut 2002;51(Suppl 6):VI1–VI9.
   PubMedGoogle Scholar
• Dingle BH, Rumble RB, Brouwers MC. The role of gemcitabine in the treatment of cholangiocarcinoma and gallbladder cancer: A systematic review. Can J Gastroenterol 2005;19:711–6.
   PubMed Web of Science ®Google Scholar
• Tan BR, Brenner WS, Picus J, Marsh S, Gao F, Fournier C, . Phase I study of biweekly oxaliplatin, gemcitabine and capecitabine in patients with advanced upper gastrointestinal malignancies. Ann Oncol 2008;19:1742–8.
   PubMedGoogle Scholar
• Andre T, Reyes-Vidal JM, Fartoux L, Ross P, Leslie M, Rosmorduc O, . Gemcitabine and oxaliplatin in advanced biliary tract carcinoma: A phase II study. Br J Cancer 2008;99:862–7.
   PubMed Web of Science ®Google Scholar
• Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, . Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med 2010;362:1273–81.
   PubMed Web of Science ®Google Scholar
• Tannapfel A, Sommerer F, Benicke M, Katalinic A, Uhlmann D, Witzigmann H, . Mutations of the BRAF gene in cholangiocarcinoma but not in hepatocellular carcinoma. Gut 2003;52:706–12.
   PubMed Web of Science ®Google Scholar
• Yoshikawa D, Ojima H, Iwasaki M, Hiraoka N, Kosuge T, Kasai S, . Clinicopathological and prognostic significance of EGFR, VEGF, and HER2 expression in cholangiocarcinoma. Br J Cancer 2008;98:418–25.
   PubMed Web of Science ®Google Scholar
• Paule B, Herelle MO, Rage E, Ducreux M, Adam R, Guettier C, . Cetuximab plus gemcitabine-oxaliplatin (GEMOX) in patients with refractory advanced intrahepatic cholangiocarcinomas. Oncology 2007;72:105–10.
   PubMed Web of Science ®Google Scholar
• Philip PA, Mahoney MR, Allmer C, Thomas J, Pitot HC, Kim G. Phase II study of erlotinib in patients with advanced biliary cancer. J Clin Oncol 2006;24:3069–74.
   PubMed Web of Science ®Google Scholar
• Yoshikawa D, Ojima H, Kokubu A, Ochiya T, Kasai S, Hirohashi S, . Vandetanib (ZD6474), an inhibitor of VEGFR and EGFR signalling, as a novel moleculartargeted therapy against cholangiocarcinoma. Br J Cancer 2009;100:1257–66.
   PubMed Web of Science ®Google Scholar
• Zhu AX, Meyerhardt JA, Blaszkowsky LS, Kambadakone AR, Muzikansky A, Zheng H, . Efficacy and safety of gemcitabine, oxaliplatin, and bevacizumab in advanced biliary-tract cancers and correlation of changes in 18-fluorodeoxyglucose PET with clinical outcome: A phase 2 study. Lancet Oncol 2009.
   Google Scholar