Gastrointestinal Clinical Trials

With an emphasis on transdisciplinary translational research, the OSUCCC-James facilitates investigator-initiated early phase clinical trials and participates in many cooperative groups.


Protocol No.PITitle
OSU-10150Mark ArnoldA prospective study for the assessment of recurrence risk in stage II colon cancer patients using ColoPrint
CALGB-80802Tony Bekaii-SaabA Phase III Randomized Study of Sorafenib Plus Doxorubicin Versus Sorafenib Alone In Patients with Advanced Hepatocellular Carcinoma (HCC).
CALGB-71002Tony Bekaii-SaabEmbedded Companion to CALGB-80702
OSU-11147Tony Bekaii-SaabA Multi-Center, Randomized, Placebo-Controlled Phase II Study of Regorafenib in Combination With FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) Versus Placebo With FOLFIRI as Second-Line Therapy in Patients with Metastatic Colorectal Cancer
OSU-11167Tony Bekaii-SaabTwo-Part, Open-Label, Multi-Center Phase 1 Study of Monoclonal Antibody CEP-37250/KHK2804 in Subjects with Advanced Solid Tumors
CALGB-71003Tony Bekaii-SaabEmbedded Companion to CALGB-80803
CALGB-151007Tony Bekaii-SaabEmbedded Companion to CALGB-80803
CALGB-80803Tony Bekaii-SaabRANDOMIZED PHASE II TRIAL OF PET SCAN-DIRECTED COMBINED MODALITY THERAPY IN ESOPHAGEAL CANCER
CALGB-70502Tony Bekaii-SaabEmbedded Companion Study to CALGB 80405
CALGB-150506Tony Bekaii-SaabEmbedded Companion Study to CALGB 80405
CALGB-60501Tony Bekaii-SaabEmbedded Companion to CALGB 80405
OSU-08078Tony Bekaii-SaabA prospective, multicenter, randomized, open-label, active-controlled, 2-parallel group, phase III study to compare efficacy and safety of masitinib at 7.5 mg/kg/day to imatinib at 400 or 600 mg in treatment of patients with gastro-intestinal stromal tumor in first line medical treatment
CALGB-580901Tony Bekaii-SaabEmbedded Companion to CALGB 80802
CALGB-150902Tony Bekaii-SaabEmbedded Companion to CALGB 80802
CALGB-60901Tony Bekaii-SaabEmbedded Companion Study to CALGB 80802
CALGB-80702Tony Bekaii-SaabA Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer
CALGB-150911Tony Bekaii-SaabEmbedded Protocol to CALGB-80702
CALGB-60905Tony Bekaii-SaabEmbedded Protocol to CALGB-80702
OSU-13081Tony Bekaii-SaabRandomized, Open Label, Phase 2 Study of MM-111 and Paclitaxel with or without Trastuzumab in Patients with Traditional and Non-Traditional HER2 Expressing Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy
OSU-13097Tony Bekaii-SaabA Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AMG 337 in Adult Subjects with Advanced Solid Tumors
OSU-13098Tony Bekaii-SaabA Phase III Study of Chemotherapy With or Without Algenpantucel-L (HyperAcute®-Pancreas) Immunotherapy in Subjects with Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer
OSU-13158Tony Bekaii-SaabA Phase Ib/II Clinical Study of BBI608 Administered with Paclitaxel in Adult Patients with Advanced Malignancies
OSU-14005Tony Bekaii-SaabA Phase 3, Multicenter, Open-label, Randomized Study of nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Subjects With Surgically Resected Pancreatic Adenocarcinoma
OSU-14059Tony Bekaii-SaabA Randomized, Double-Blind, Phase 3 Study of the JAK1/2 Inhibitor, Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First-Line Chemotherapy
OSU-11113P. Mark BloomstonA Randomized Prospective Multicenter Trial of Pancreas Resection with and without Routine Intraperitoneal Drainage
OSU-10110P. Mark BloomstonCytopathologic Margin Evaluation in Patients Undergoing Pancreatic Cancer Resection
OSU-10015P. Mark BloomstonA Banking Facility for Biological Samples and Clinical Data to Study Pancreatic Tumors
OSU-13184Kristen CiomborA Phase 1 Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics and Safety of Crizotinib in Advanced Cancer Patients
OSU-13159Kristen CiomborA Phase II Clinical Study of BBI608 in Adult Patients with Advanced Colorectal Cancer
OSU-14018Kristen CiomborA Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects With Advanced Solid Tumors
OSU-07013Albert de la ChapelleThe Identification of Predisposing Genes in Hyperplastic Polyposis (HPP)
OSU-11182Richard GoldbergA Phase II Study of the Combination of Aflibercept (VEGF-Trap) plus Modified FOLFOX 6 in Patients with Previously Untreated Metastatic Colorectal Cancer
OSU-12170Heather HampelThe Ohio Colorectal Cancer Prevention Initiative: Universal Screening for Lynch Syndrome
OSU-05060Kimberly KellySurvey of PCP's Comfort with Management of HBOC and HNPCC.
OSU-10036Hooman KhabiriA Humanitarian Device Exemption Treatment Protcol of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma
OSU-06002Greg LesinskiA Storage Facility for Peripheral Blood Obtained from Patients with Gastrointestinal Malignancies.
OSU-08028Ryan NiederkohrRetrospective Evaluation of the Accuracy of PET/CT with Respect to Surgiscal Planning in Patients with Colorectal Cancer
OSU-13268Anne NoonanAn International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan plus Low-Dose Gemcitabine Versus Placebo plus Low-Dose Gemcitabine in Patients with Metastatic (Stage IV) Pancreatic Adenocarcinoma Who Received at Least Two Prior Treatments (PANCRIT-1)
OSU-08073Electra PaskettEnhancing Colorectal Cancer Screening in Primary Care: (TIME-Teaching Interventions to Educate and Motivate)
OSU-08168Electra PaskettCBPR Strategies to Increase Colorectal Cancer Screening in Ohio Appalachia
OSU-12230Electra PaskettOhio Colorectal Cancer Prevention Initiative: Adherence to Colon Cancer Screening (ACCS) Project:Your Personal Prescription For Colorectal Cancer Screening.
OSU-10025Stephen PovoskiRestrospective Evaluation of Patients Undergoing Surgery and Same-Day Intravenous Administration of 18F-FDG
OSU-13053Sameek RoychowdhuryPrecision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing
OSU-14054Sameek RoychowdhuryModular phase II study to link targeted therapy to patients with pathway activated tumors:Module 3 - MEK162 for patients with RAS/RAF/MEK activated tumors
NCCTG-N1048Carl Schmidt A Phase II/III trial of Neoadjuvant FOLFOX, with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision.
RTOG-1112Terence WilliamsRandomized Phase III Study of Sorafenib versus Stereotactic Body Radiation Therapy followed by Sorafenib in Hepatocellular Carcinoma
OSU-13176Chadwick WrightPET/CT-Derived Hepatopulmonary Shunt Fraction Following Yttrium-90 Radioembolization
AMC-087Christina WuPhase I Trial of Cabozantinib (XL184) for Advanced Solid Tumors in Persons with HIV Infection
OSU-11131Christina WuA Phase II Study of Panitumumab in Combination with FOLFIRI after Progression on FOLFIRI Plus Bevacizumab in KRAS Wild Type Metastatic Colorectal Cancer.
OSU-12054Evan WuthrickA Phase I Trial of MEK Inhibitor GSK1120212 in Combination with Neoadjuvant 5-Fluorouracil Chemoradiation in the Treatment of KRAS, BRAF, and NRAS-Mutant Rectal Cancers
RTOG-1010Evan WuthrickA Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-overexpressing Esophageal Adenocarcinoma

The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) 300 W. 10th Ave. Columbus, OH 43210 Phone: 1-800-293-5066 | Email: jamesline@osumc.edu