Ongoing Clinical Trials Actively Recruiting Patients With Gastrointestinal Cancers

This Clinical Trials Resource Guide is meant to increase awareness of currently recruiting NCI- or academic institution–sponsored clinical studies for your patients with gastrointestinal cancers. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov, and include nonrandomized, randomized, interventional, and observational studies.

Study Type: Observational

Study Title: Tissue Procurement for Gastric Cancer, Gastrointestinal Stromal Tumors (GIST), Esophageal Cancer, Pancreas Cancer, Hepatocellular Cancer, Biliary Cancer, Neuroendocrine, Peritoneal Mesothelioma, Anal Cancer and Colorectal Cancer in Patients Undergoing Surgery or Biopsy

Study Sponsor and Collaborators: University of Chicago

Purpose: To collect and store normal and malignant tissue and blood samples from patients with gastric cancer, gastrointestinal stromal tumor, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine tumor, peritoneal mesothelioma, anal cancer, and colorectal cancer to create a database for the collected tissue and allow access to relevant clinical information for current and future protocols. An additional goal is to create tissue microarrays for each gastrointestinal cancer subtype to facilitate future molecular studies.

Ages Eligible for Study: Not available

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Collect and store blood samples (time frame: 1 year); create a database for collected tissue (time frame: 1 year)

Principal Investigator: Daniel Catenacci, MD, University of Chicago; 773-702-7596; dcatenac@medicine.bsd.uchicago.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01416714

Study Title: Investigation of the Immune Response to Gastrointestinal Tumors and Development of Novel Biomarkers for the Presence of Gastrointestinal Cancer

Study Sponsor and Collaborators: University of Pittsburgh

Purpose: To learn more about the immune response to more common gastrointestinal cancers. The first goal of this study is to collect blood and tissues samples from patients with early- or late-stage gastrointestinal cancers. The samples will be evaluated to better understand the immune response to these two cancers. The second goal is to evaluate the specimens of these patients for changes and genetic markers that correlate with the presence of cancer. The information gathered from the studies will enhance the ability of researchers to design, conduct, and monitor novel immunotherapeutic protocols for the treatment of patients with gastrointestinal cancer.

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: To collect cells from the peripheral blood, tumor draining lymph nodes, and tumor infiltrating lymphocytes in patients with early- or late-stage gastrointestinal cancers (time frame: not available)

Principal Investigator: Herber J. Zeh, MD, University of Pittsburgh; 412-692-2852; zehh@upmc.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00633334

Study Title: Prevention of Nausea and Vomiting Secondary to FOLFIRINOX Chemotherapy in Gastrointestinal Cancer Patients

Study Sponsor and Collaborators: Barbara Ann Karmanos Cancer Institute; National Cancer Institute

Purpose: To study fosaprepitant dimeglumine in the prevention of nausea and vomiting in patients with gastrointestinal cancer receiving combination chemotherapy. Antiemetic drugs, such as fosaprepitant dimeglumine, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy.

Ages Eligible for Study: 19 years and older

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Control of vomiting (time frame: from 0–120 hours after first course of chemotherapy)

Principal Investigator: Minsig Choi, MD, Barbara Ann Karmanos Cancer Institute; 800-527-6266

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01504711

Study Title: A Pilot/Phase II Study of Gamma Knife Radiosurgery for Brain Metastases Using 3Tesla MRI and Rational Dose Selection

Study Sponsor and Collaborators: Yale University

Purpose: To collect prospective data for use as a comparator for future subsequent studies attempting to increase the efficacy or reduce the toxicity of gamma knife radiosurgery

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Rate of local control over time (RECIST criteria; time frame: up to 2 years)

Principal Investigator: James B. Yu, MD, Yale University; 203-785-5703; james.b.yu@yale.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02005614

Study Title: A Feasibility and Registration Study of Proton Radiotherapy for Upper Gastrointestinal Malignancies

Study Sponsor and Collaborators: Abramson Cancer Center of the University of Pennsylvania

Purpose: To determine feasibility and the acute toxicity profile of proton therapy with concurrent continuous-infusion fluorouracil chemotherapy. Secondary objectives are to determine late toxicities and to generate preliminary data on clinical efficacy.

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Serious adverse events; patient is unable to tolerate more than 25% of treatments using proton radiotherapy; acute toxicity (time frame: 90 days)

Principal Investigator: John Plastaras, MD, PhD, Abramson Cancer Center of the University of Pennsylvania; 855-216-0098; Penncancertrials@emergingmed.com

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01449864

Study Title: Influence of Meditation-Based Breathing Training on Target Motion Management and Distress During Radiation for Abdominal and Lung Malignancies

Study Sponsor and Collaborators: Albert Einstein College of Medicine of Yeshiva University; National Cancer Institute

Purpose: This randomized pilot clinical trial is studying mediation-based breathing training in improving target motion management and reducing stress in patients with abdominal or lung cancer undergoing radiation therapy. Meditation-based breathing training may decrease breathing-related movement and the amount of stress in patients with abdominal or lung cancer undergoing radiation therapy.

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Change in duty cycle, defined as the fraction of time of the breathing cycle that the beam is on, before and after breath coaching (time frame: baseline to up to 5 weeks). Changes in the length of the end expiration or end inspiration, defined as when the breathing trace or internal motion change direction (time frame: baseline to up to 5 weeks). Changes in gate width (time frame: baseline to up to 5 weeks).

Principal Investigator: Alyson Moadel, PhD, Albert Einstein College of Medicine/Montefiore Medical Center; 718-430-2380; alyson.moadel@­einstein.yu.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01939210

Study Type: Phase I nonrandomized/interventional

Study Title: Phase I Study of Aurora A Kinase Inhibitor (MLN8237) Given in Combination With Selective VEGFR Inhibitor Pazopanib (Votrient) for Therapy in Solid Tumors

Study Sponsor and Collaborators: University of Illinois at Chicago

Purpose: This phase I dose escalation study will evaluate alisertib, an Aurora A kinase inhibitor, when given in combination with the selective vascular endothelial growth factor receptor (VEGFR) inhibitor pazopanib in patients with advanced, previously treated nonhematologic solid tumors.

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Optimally tolerated dose (time frame: at end of cycle 1 [approximately day 21]; complete all planned treatment for cycle 1 (defined as 14 doses of alisertib and daily pazopanib without dose-limiting toxicity and patients are able to start cycle 2 with no more than a 2 week delay).

Principal Investigator: Arkadiusz Z. Dudek, MD, University of Illinois at Chicago; 312-413-8878; adudek@uic.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01639911