Gastrointestinal cancer represent one of the major reasons for tumor related death in the United States. Current treatment options are limited to surgery, chemotherapy, radiation therapy and molecular targeted therapy and new treatment options are urgently needed. We have currently six clinical trials open for patients with GI cancer. In addition we have been able to enroll patients into two other studies, which have completed enrollment: Currently open studies by organ: Hepatocellular carcinoma 11-C-0102 I Sorafenib and TRC105 in HCC 1st line treatment with a combination of sorafenib+the vascular targeting agent Trc105 in patients with HCC. The phase portion of this study will be complete in the next few weeks. 11-C-0181 G TRC105 in HCC Single arm study evaluation the effect of Trc105 monotherapy in patients with HCC, who progressed on sorafenib. We have enrolled 9 patients and expect a preliminary efficacy analysis soon. 13-C-0120 A anti-CTLA4 &ablative therapy This study was recently opened. Here we test the combination of ablative therapies (RFA/Tace) in combination with anti-CTLA4. 12-C-0156 C GC33 in Hepatocellular Ca This is a multicenter study investigating the effect of anti-GC33 for the treatment of patients with HCC, who progressed on sorafenib. The study has completed its enrollment. Pancreatic carcinoma 13-C-0009 E NPC-1C Gem in Pancreatic Ca This is a multicenter study testing the combination of NPC1, an Ab directed against a glycosylated form of Muc5A in pancreatic cancer in combination with gemcitabine in patients who progressed on FOLFIRINOX. We have completed the phase I portion of the study and it is now open at multiple sites. 11-C-0267 D GVAX Pancreas Vaccine This is a multicenter randomized phase II study testing the combination of mesothelin expressing attenuated listeria in combination with GVAX. The study has completed its enrollment and the preliminary results were reported at ASCO. Colon Cancer 12-C-0187 D ISIS 183750 &Irinotecan This is a study testing the combination of antisense to eIF4e in combination with irinotecan in patients with colon cancer who progressed on irinotecan. We completed the phase I portion of enrollment. 13-C-0147 Gem Docetaxel Colorectal Ca This is a multicenter trial, testing the combination of Gem+docetaxel in Patients with Relapsed or Refractory Metastatic Colorectal Adenocarcinoma with Methylated CHFR and/or Microsatellite Instability Phenotype. In addition we perform clinical research on patients with the aim to develop new protocols. These studies include the risk of vascular targeting effects on bleeding events in HCC, meta-analysis on first and second line treatment in heaptobiliary cancer as well as studies on fibrolamellar HCC

National Institute of Health (NIH)
National Cancer Institute (NCI)
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National Cancer Institute Division of Basic Sciences
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Duffy, A G; Makarova-Rusher, O V; Ulahannan, S V et al. (2016) Modulation of tumor eIF4E by antisense inhibition: A phase I/II translational clinical trial of ISIS 183750-an antisense oligonucleotide against eIF4E-in combination with irinotecan in solid tumors and irinotecan-refractory colorectal cancer. Int J Cancer 139:1648-57
Le, Dung T; Wang-Gillam, Andrea; Picozzi, Vincent et al. (2015) Safety and survival with GVAX pancreas prime and Listeria Monocytogenes-expressing mesothelin (CRS-207) boost vaccines for metastatic pancreatic cancer. J Clin Oncol 33:1325-33
Duffy, A G; Ulahannan, S V; Cao, L et al. (2015) A phase II study of TRC105 in patients with hepatocellular carcinoma who have progressed on sorafenib. United European Gastroenterol J 3:453-61
Ulahannan, Susanna V; Rahma, Osama E; Duffy, Austin G et al. (2015) Identification of active chemotherapy regimens in advanced biliary tract carcinoma: a review of chemotherapy trials in the past two decades. Hepat Oncol 2:39-50
Malek, Nisar P; Schmidt, Sebastian; Huber, Petra et al. (2014) The diagnosis and treatment of hepatocellular carcinoma. Dtsch Arztebl Int 111:101-6
Eggert, Tobias; McGlynn, Katherine; Greten, Tim F et al. (2014) Response to fibrolamellar hepatocellular carcinoma versus conventional hepatocellular carcinoma: better 5-year survival or artefactual result of research methodology? Gut 63:1524
Malka, David; Cervera, Pascale; Foulon, Stephanie et al. (2014) Gemcitabine and oxaliplatin with or without cetuximab in advanced biliary-tract cancer (BINGO): a randomised, open-label, non-comparative phase 2 trial. Lancet Oncol 15:819-28
Duffy, Austin; Wilkerson, Julia; Greten, Tim F (2013) Hemorrhagic events in hepatocellular carcinoma patients treated with antiangiogenic therapies. Hepatology 57:1068-77
Eggert, Tobias; McGlynn, Katherine A; Duffy, Austin et al. (2013) Fibrolamellar hepatocellular carcinoma in the USA, 2000-2010: A detailed report on frequency, treatment and outcome based on the Surveillance, Epidemiology, and End Results database. United European Gastroenterol J 1:351-7
Greten, T F; Malek, N P; Schmidt, S et al. (2013) [Diagnosis of and therapy for hepatocellular carcinoma]. Z Gastroenterol 51:1269-326

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