UC12-0033: A genotype-guided dosing study of mFOLFIRINOX in previously untreated patients with advanced gastointestinal malignancies.
Aims: This study is being done to determine whether a certain dose of a chemotherapy drug (irinotecan) can be tolerated as part of a combination of drugs. There is a combination of chemotherapy drugs often used to treat your type of cancer. 5-FU, leucovorin, irinotecan and oxaliplatin; the combination is known as "FOLFIRINOX." FOLFIRINOX is a current regimen used for patients with advanced pancreatic cancer. It was recently shown in a separate clinical trial to increase survival compared to another commonly used drug in pancreatic cancer, gemcitabine. FOLFIRINOX is also a reasonable regimen for patients with other advanced cancers of the gastroinestinal tract, including colon cancer, rectal cancer, esophagus cancer, stomach cancer, gall bladder cancer, bile duct cancer, ampullary cancer, and cancers with an unknown primary location.
Diagnosis: Esophageal Cancer 
Principal Investigator: Robert Marsh, MD
IRB Approval Number: EH12-266
Sponsor: University of Chicago
Contact: Interested patients should contact research nurse Tara Flanagan, RN at 847.570.1768
Open to Enrollment: Yes

N1048: A Phase II/III Trial of Neoadjuvant FOLFOX with Selective Use of Combined Modality
Aims: The purpose of this study is to compare the effects, both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy using a combination regimen known as FOLOX (the drugs 5-flurouracil (5-FU), oxaliplatin and leucovorin) and selective use of the standard treatment, depending on response to the FOLFOX. The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved and have been used routinely since 2002 to treat patients with advanced colorectal cancer.
Diagnosis: Advanced Colorectal Cancer
Principal Investigator:
 Joseph Muldoon, MD
IRB Approval Number: EH12-468
Sponsor: Alliance in Clinical Trials in Oncology
Contact: Interested patients should contact research nurse Claudia Fredian, RN, OCN, CCRP at 847.570.1512, cfredian@northshore.org
Open to Enrollment: Yes

Celgene ABI-007-PANC-003: A Phase 3, Multicenter, Open-label, Randomized Study of nab® Paclitaxel Plus Gemcitabine Alone as Adjunct Therapy in Subjects with Surgically Resected Pancreatic Adenocarcinoma
Aims: The purpose of this study is to determine whether the addition of nab®-paclitaxel to gemcitabine will help to delay the cancer from coming back after surgery. Gemcitabine is a drug commonly used after pancreatic resection. 
Diagnosis: Pancreatic Adenocarcinoma
Principal Investigator: Robert Marsh, MD 
IRB Approval Number: EH14-056
Sponsor: Celgene Corporation
Contact: Interested patients should contact research nurse Elita Fine, RN at 847.570.2698
Open to Enrollment: Yes

Defining the Role of Microbes in the Pathogenesis of Intestinal Anastomotic Leak Via Serial Endoscopic Surveillance
Aims: To evaluate the safety and feasibility of performing repeated limited sigmoidoscopy, termed serial endoscopic surveillance (SES), in ten (10) patients in the post-operative period of surgical recovery following a low anterior resection (LAR) and loop ileostomy, a standard procedure for rectal cancer. The study will examine intestinal bacterial composition and function to healing and the risk of anastomotic leak (leak at the site of surgical connection). 
Diagnosis:Colorectal Cancer
Principal Investigator: Joseph Muldoon, MD 
IRB Approval Number: EH14-272
Sponsor: American Society of Colon and Rectal Surgeons (ASCRS) Research Foundation in collaboration with the University of Chicago
Contact: Interested patients should contact Jen Jaffee at 847.570.2803, jjaffee@northshore.org
Open to Enrollment: Yes

AstraZeneca POLO: A Phase III, Randomized, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy, Protocol No. D081FC00001
Aims: This study is being carried out to see if a new drug being tested, called Olaparib, is effective in treating your pancreatic cancer and preventing it from coming back as quickly as it could otherwise without any anti-cancer drugs during a pause in chemotherapy. The alternative approach in this situation is not to take further anti-cancer drugs until the cancer comes back or to continue on chemotherapy.
Diagnosis: gBRCA Mutated Metastatic Pancreatic Cancer
Principal Investigator: Robert Marsh, MD
IRB Approval Number: EH14-363
Sponsor: AstraZeneca
Contact: Interested patients should contact research nurse Elita Fine, RN at 847.570.2698
Open to Enrollment: Yes

The Pancreatic Sample Repository
Aims: Collect blood, pancreatic secreions and pancreatic tissue from patients undergoing surgery for pancreatic diseases, including cancer and store these samples in a repository for future studies done at NorthShore or at collaborating institutions
 Diagnosis: Any pancreatic disease
Principal Investigator: Karen Kaul, MD 
IRB Approval Number: EH02-186
Sponsor: NorthShore University HealthSystem
Contact: Interested patients should contact Susan Jane Stocker, LPN, BLS,CCRP at 847.570.1322, sstocker@northshore.org or Gnathan Carpenter, RN at 847.570.2949, gcarpenter@northshore.org
Open to Enrollment: Yes

Clinical Pancreatic Cancer Database
Aims: Capture, review, and compare medical information, including symptoms, treatmetns and complications that people with pancreatic diseases have and store this information for future research studies.
Diagnosis: Any pancreatic disease
Principal Investigator: Mark S. Talamonti, MD
IRB Approval Number: EH08-197T
Sponsor: NorthShore University HealthSystem
Contact: Interested patients should contact Susan Jane Stocker, LPN, BLS,CCRP at 847.570.1322, sstocker@northshore.org or Gnathan Carpenter, RN at 847.570.2949, gcarpenter@northshore.org
Open to Enrollment: Yes

A Phase III Clinical Trial of Intr-arterial TheraSphere in the Treatment of Patients with Unresectable Hepatocellular Carcinoma (HCC)
Aims: The purpose of this study is to evaluate TheraSphere® in the treatment of patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib therapy is planned. Patients will be randomized to receive either TheraSphere and sorafenib or sorafenib alone. TheraSphere is a medical device that delivers radiation directly to the liver tumor to slow or stop the growth of the tumor.
Diagnosis: Hepatocelluar Carcinoma (HCC)
Principal Investigator: Claus Fimmel, MD
IRB Approval Number: EH14-254
Sponsor: BTG International Inc./ Biocompatibles UK Ltd
Contact: Interested patients should contact Colleen Leonard at 847.570.3558, cleonard@northshore.org 
Open to Enrollment: Yes     

A221303: Randomized Study of Early Palliative Care Integreated with Standard Oncology Care Versus Standard Oncology Care Alone in Patients with Incurable Lung or Non-Colorectal Gastrointestinal Malignancies
Aims: The purpose of this research study is to see whether patients who receive care from palliative care doctors and nurses at an earlier time in their disease, along with their regular cancer care, will experience less emotional and physical issues from their cancer.
Diagnosis: Incurable Non-Colorectal Gastrointestinal Malignancies
Principal Investigator: Jennifer Obel, MD
IRB Approval Number: EH15-215
Sponsor: Alliance
Contact: Interested patients should contact research nurse Susan Greve, RN at 847.570.1183
Open to Enrollment: Yes

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