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Clinical Trials

Here at the Pancreas Center, advancing the early detection, care, and treatment of pancreatic cancer through research is part of our mission. Already intrepid in our current treatment tactics, we believe there are still opportunities for novel and improved detection and therapeutic options yet to be developed. The Pancreas Center team is committed to being on the leading edge of developing these breakthrough therapies by better understanding the causes of pancreatic cancer through basic research and exploring innovative treatments through translational research and clinical trials.

Below is a listing of Pancreas Center clinical trials that are currently open for enrollment. If you have any questions about the trials listed, please contact the enrolling physician, or contact the Pancreas Center clinical trials coordinator at 212.305.9467. It is important to understand that participation in any clinical trial is completely voluntary for the patient. Common reasons for joining a clinical trial include:
  • Playing a more active role in your own health care
  • Gaining access to innovative screening and therapies before they become widely available
  • Helping others by contributing to advancements in medical research
List of Trials (Click titles for more information)

Trial: Quality of Life for Patients Undergoing Pancreatic Resection
Description: Pancreatic surgery is reputed to result in poor long-term quality of life, a belief that our experience suggests is poorly founded. This study uses a widely accepted questionnaire focusing on digestive health to assess quality of life after pancreatic surgery.

Trial: Phase II Study of Gemzar, Taxotere and Xeloda (GTX) for Adjuvant Pancreatic Cancer Treatment
Description: GTX is a combination of Gemcitabine, Taxotere and Xeloda, which has been shown to be synergistic in laboratory models. The primary aim of this study is to determine whether there is any toxicity associated with the new regimen.

Trial: Columbia Pancreatic Cancer Prevention Program Registry and Tissue Bank for High Risk Individuals
Description: The specific aims of this project are to create a registry, as well as a blood and a tissue bank for individuals with and at high-risk for pancreatic cancer. The personal data derived from the registry, correlated with biological information derived from the tissue specimens will allow for future investigative studies of pancreatic cancer etiology and tumor biology.

Trial: Phase II Study of a Biochemically Synergistic Regimen for Advanced Adenocarcinoma of the Biliary Tree with Gemzar, Taxotere and Xeloda (GTX)
Description: After initial presentation of the GTX regimen (in pancreatic cancer) a number of practitioners began using the regimen for pancreatic cancer patients. Several of these investigators began using the same regimen for patients with unresectable and metastatic biliary tree cancers such as cholangiocarcinoma. Personally, our group has treated 5 patients with the GTX regimen, and have documented 2 partial responses and 1 stable disease out of 3 patients with cholangiocarcinoma and 2 with gall bladder cancer. We therefore believe that it will show efficacy in this disease. The primary goals of this trial are to determine response rate to this regimen in patients with metastatic biliary tree cancers (stage 4) and to determine response rate to this regimen in patients with unresectable stage 3 biliary cancers.

Trial: Phase II Study of Capecitabine and Temozolomide for Progressive, Differentiated, Metastatic Neuroendocrine Cancers
Description: The primary goal is to determine the radiologic response rate to this regimen in progressive, metastatic, differentiated neuroendocrine cancers, including carcinoid tumors and excluding small cell cancer of lung or other origin (e.g. GI tract) which are poorly differentiated.

Trial: Phase II Study of Inoperable Nonmetastatic Pancreatic Cancer (Stage IVA) with Neoadjuvant Gemzar, Taxotere and Xeloda (GTX) and Radiation with Gemzar
Description: The purpose of this study is to determine whether an experimental drug combination consisting of Gemzar, Taxotere, and Xeloda (called GTX) when followed by radiation therapy plus low-dose Gemzar, is safe and effective in treating advanced pancreatic cancer as well as to study and enhance the utility of PET scans in the evaluation of patients with pancreatic cancer. The evolution of our GTX regimen was cerefully developed over the past three years from laboratory and clinical work. Many different combinations of these 3 agents were investigated in the laboratory to determine the best combination to achieve biochemical synergy while decreasing the concentration of each drug so as to minimize toxicity to patients without losing the anti-tumor effect.

Trial: MRCP with Secretin-Stimulation for the Evaluation of Pancreatic Endocrine and Exocrine Function Following Surgical Resection for Pancreatic Adenocarcinoma
Description: The aim of this study is to determine whether S-MRCP as well as traditional MRI of the pancreas, in comparison to clinical and serological markers, will allow us to quantify the pancreas' ability to secrete both hormones and digestive enzymes. In order to prevent and treat complications following pancreatic resection, doctors must accurately gauge pancreatic function both before and after surgery. However, most methods of measurement are either invasive or innacurate. A new test called secretin-enhanced magnetic resonance cholangiopancreatography (S-MRCP) uses MRI technology enhanced by the use of the hormone secretin to more clearly visualize the ducts of the pancreas. S-MRCP is already known to be an accurate test to look for the amount of digestive enzymes that the pancreas is producing however, it has not been evaluated extensively in patients undergoing surgery for their cancer.

Trial: Secretin-Stimulated MRCP as an Early Screening Modality for Pancreatic Ductal Abnormalities in Patients at High Risk for Pancreatic Adenocarcinoma: A Pilot Study
Description: The aim of our study is to evaluate the utility of SMRCP in detecting carcinoma and precancerous lesions in patients with a significant family history of pancreatic adenocarcinoma. Our hypothesis is that SMRCP is superior to traditional CT or MRI in detecting early pancreatic neoplasms, and approaches the accuracy of EUS. The primary outcome that we will be studying will be concordance of SMRCP and SEUS. Secondarily, we will be measuring positive predictive value of SMRCP, in comparison with EUS and ERCP in identifying neoplasm in those patients who undergo surgical resection during this study

Trial: Molecular Genetics and Epidemiology of Pancreatic Cancer in Ashkenazi Jewish Patients
Description: Up to 15% of pancreatic cancers have an inherited disease component. Several gene abnormalities and inherited cancer syndromes have been shown to increase the risk of developing pancreatic cancer, including the breast ovary cancer syndrome (BRCA mutations). Several studies have demonstrated that germline BRCA1 and BRCA2 mutations are associated with an increased risk of malignancies, including breast, ovarian and more recently pancreatic cancer. BRCA mutations are not common in the general population however, they are more common in the Ashkenazi Jewish population. Several mutations are present in Ashkenazi Jewish populations that modify cancer risk and treatment response which have been shown to interact directly with BRCA genes. Testing for BRCA1 and BRCA2 mutations in relatives of hereditary pancreatic cancer patients may allow early screening, treatment, and resection of pre-malignant tissue or malignant lesions.

Trial: Meaning-Focused Group Intervention for Patients with Recurrent or Metastatic Pancreatic Cancer Aimed at Improving Self-Transcendence and Quality of Life
Description: The main goal for this project is to determine the feasibility of offering a structured 8 week group program for patients with recurrent or metastatic pancreatic cancer that aims to improve their quality of life.

Trial: Registry and Tissue Bank for High Risk Individuals Study
Description: To create a registry of individuals with, or at high risk of developing, pancreatic cancer

Trial: Stool DNA Testing: A Feasibility Study
Description: Evaluate the efficacy of detecting pancreatic abnormalities in the stool.

Trial: Depression and Tumor Burden in Pancreatic Adenocarcinoma Study
Description: The purpose of the study is to assess the relationship between mood and tumor size in pancreatic cancer

Trial: Molecular Genetics and Epidemiology Study
Description: To determine the frequency of gene mutations in patients with, or at a high risk for developing, pancreatic cancer


If you are interested in other clinical trial opportunities within Columbia University, click here.

 
 
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