Research Initiatives for Novel Future Therapies

Pancreas Center Active Clinical Trials and Non-Interventional Protocols

Active Clinical Trials

A Phase 3, Randomized, Double Blind, Placebo Controlled, Multicenter Study of Maintenance Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy 

  • Clinical Setting: Following first line treatment in patients with metastatic pancreatic cancer
  • Study Description: This research study is being conducted to see if a new treatment using a study drug called Olaparib given after platinum based chemotherapy treatments can reduce the risk of pancreatic cancer from growing back. Participants will receive either Olaparib or placebo and will stay on the research study for as long as they are not getting worse.
  • This study is only open to patients who have a specific gene that causes pancreatic cancers in some familial cases.
  • Principal Investigator: Paul Oberstein, MD 646-317-6085

A Randomized, Double-blind, Placebo-controlled Phase 2 Study of MM-141 plus Nab-Paclitaxel and Gemcitabine versus Nab-Paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer

  • Clinical Setting: First line treatment of metastatic pancreatic cancer 
  • Study Description: This is a randomized, double blind, multicenter study in newly diagnosed pancreatic cancer patients, approximately 60% of those tested have high free IGF-1 levels in their blood. Because MM-141 targets IGF-1R, only those patients with high free IGF-1 levels will be able to get treated on this study.
  • This is a randomized, double-blind, placebo-controlled Phase 2 study of MM-141 plus nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine in front-line metastatic pancreatic cancer patients.
  • Principal Investigator: Paul Oberstein, MD 646-317-6085

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination with nab-Paclitaxel Plus Gemcitabine Compared with Placebo Plus nab-Paclitaxel and Gemcitabine in Subjects with Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma

  • Clinical Setting: First line treatment of metastatic pancreatic cancer 
  • Study Description: The purpose of the study is to compare the efficacy (how well the drug works) and safety (how well the drug is tolerated) of the study drug, PEGPH20 compared with Placebo (normal saline, that is, a mixture of salt and water with an amount of salt similar to body fluids) in combination with two chemotherapy drugs nab-paclitaxel (NAB) and gemcitabine (GEM). 
  • The study will answer whether the experimental treatment (PEGPH20 with NAB and GEM) is as good as or better than Placebo with NAB and GEM. 
  • Principal Investigator: Paul Oberstein, MD 646-317-6085

Immunotherapy Protocols

A Phase 1/2 Study of the Safety and Efficacy of Ulocuplumab Combined with Nivolumab in Subjects with Advanced or Metastatic Solid Tumors

  • Clinical Setting: Second line treatment of metastatic pancreatic cancer
  • Study Description: This study is based on new research that attempts to allow the immune system to enter tumor, and simultaneously activate the immune system in hopes to attack the tumor.
  • This study is open to patients who are physically well enough to perform self-care, ambulatory, and able to perform light duties.
  • Principal Investigator: Gulam A. Manji, MD 212-305-0592

An Open-Label Phase 1b Study of the Safety and Tolerability of Atezolizumab (anti-PDL1 antibody) Administered in Combination with Gemcitabine and nab-Paclitaxel in Subjects with Metastatic Pancreatic Cancer

  • Clinical Setting: First line treatment of metastatic pancreatic cancer
  • Study Description: This study is based on the hypothesis that chemotherapy will expose the tumor and allow for more effective killing of cancer cells by the immune system.
  • This study is open to patients who are physically well enough to perform self-care, ambulatory, and able to perform light duties.
  • Principal Investigator: Gulam A. Manji MD, 212-305-0592

Supportive Care

Randomized Study of Early Palliative Care Integrated With Standard Oncology Care Versus Standard Oncology Care Alone In Patients With Incurable Lung or Non- Colorectal Gastrointestinal Malignancies

  • Clinical Setting: Newly diagnosed incurable gastrointestinal or lung cancer including metastatic pancreatic cancer.
  • Study Description: The study intervention consists of the early integration of palliative care services into standard oncology care in an outpatient setting for patients with advanced lung and non-colorectal gastrointestinal malignancies who are not being treated with curative intent.
  • The palliative care services provided to patients who are randomly selected for the intervention will be provided by board certified physicians and/or advanced practice nurses and will focus on the following areas: 
    1. developing and maintaining the therapeutic relationship with the patients and family caregivers; 
    2. assessing and treating patient symptoms; 
    3. providing support and reinforcement of coping with advanced cancer in patients and family caregivers; 
    4. assessing and enhancing prognostic awareness and illness understanding in patients and family caregivers; 
    5. assisting with treatment decision-making; and 
    6. end-of-life care planning.
  • Principal Investigator: Paul Oberstein, MD 646-317-608

Non-Interventional Protocols

CAM Registry: A Registry of Complementary/Alternative Medicine (CAM) Services (Intended for Correlation with Cancer Clinical Symptoms)

  • Clinical Setting: Patients with pancreas or other GI or Thoracic cancer who are receiving complementary or alternative treatments (CAM) through the Integrative Therapy Program.
  • Study Description: The Integrative Therapy Program at Columbia University provides multiple services to patients with cancer who are receiving treatment at Columbia University. These treatments include the provision of nutrition counseling, acupuncture treatments, aromatherapy, reiki, reflexology, meditation, yoga and massage therapy to patients in active treatment and survivors.
  • This registry will collect information about the use of these services and the characteristics of patients who use these services.
  • Principal Investigator: Paul Oberstein, MD 646-317-6085

Harmonic Motion Imaging of Resected Pancreas Specimens

  • Clinical Setting: Scheduled surgery for pancreatic cancer
  • Study Description: This is a prospective study to evaluate a new kind of ultrasound device to measure the tissue in the pancreas and pancreatic cancer. The measurement will be done after surgery is performed on the part of pancreas that has been removed. After this, the specimen is sent to a special laboratory to conduct the unique ultrasound measurement. After the measurement is performed, the specimen will be transferred back to the pathologist who will analyze the specimen in the usual fashion.
  • Principal Investigator: Ken Olive, PhD, 212-851-4678

Database Shared Resource Protocol (DBSR)

  • Clinical Setting: CUMC patients diagnosed or at risk for cancer
  • Study Description: The purpose of this study is to create a database to promote clinical research to better understand, prevent and treat cancer at Columbia University Medical Center (CUMC).
  • This database will link health and lifestyle information to human samples such as blood, saliva, urine, and tissue to study the incidence and progression of cancer.
  • Principal Investigator: Katherine D. Crew, MD, MS (212) 305-1732

Safety of auto-transfusion during Pancreatic Surgery

  • Clinical Setting: Scheduled surgery for pancreatic cancer
  • Study Description: This is a prospective study to ultimately assess the safety of transfusing patients their own blood during pancreatic cancer surgery if transfusion is necessary. The question being studied at this point is the number of pancreatic tumor cells circulating in patients’ blood at the time of surgery, and comparing with the blood lost at surgery.
  • Principal Investigator: Michael Kluger, MD, 212-305-6514

Quality of Life in Pancreatic Disease

  • Clinical Setting: 5 years post pancreatic surgery.
  • Study Description: This is a prospective study on patients that have undergone pancreatic surgery for any cause.
  • The purpose of this research is to better understand the impact of pancreatic surgery on patients’ quality of life with regard to pain, diabetes, diet and need for further interventions after pancreatic surgery. To achieve this, patients will be given questionnaires specifically designed for this purpose.
  • Principal Investigator: Michael Kluger, MD, 212-305-6514

Nanoknife Surgery Outcomes

  • Clinical Setting: IRE (nanoknife) patients treated at Columbia
  • Study Description: This is a retrospective study looking at IRE surgery cases outcomes through 90 days at Columbia University.
  • Principal Investigator: Michael Kluger, MD, 212-305-6514

CITR: Collaborative Islet Transplant Registry

  • Clinical Setting: scheduled islet cell transplant surgery.
  • Study Description: This study does not involve treatment or intervention. This is a data collection study in which patients scheduled to have or that have had islet cell transplant surgery can participate.
  • The purpose of this research is to expedite progress and promote safety in islet cell transplantation through the collection, analysis, and communication of comprehensive and current data on all islet cell transplants performed in North America, Europe and Australia. Columbia University is a collaborating institution on this study.
  • Principal Investigator: Beth Schrope, MD, 212-305-9441