The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies that are focused on novel drug regimens in gallbladder and biliary tract cancers. These trials are attempting to determine the best dosages, side-effect profiles, and effectiveness of new combinations of chemotherapies for metastasized cancers.
All of the studies listed here are on the National Institutes of Health website at ClinicalTrials.gov.
PHASE I
Study Title: A Phase Ib Study of Guadecitabine (SGI-110) and Durvalumab (MEDI 4736) in Patients With Advanced Hepatocellular Carcinoma, Pancreatic Adenocarcinoma, and Cholangiocarcinoma/Gallbladder Cancer
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: University of Southern California/National Cancer Institute/Van Andel Research Institute
Purpose: To determine the best dosage of guadecitabine and its effects when combined with durvalumab in treating patients with metastasized liver, pancreatic, bile duct, or gallbladder cancer
Primary Outcome Measures: Dose-limiting toxicities and the maximum tolerated dose/recommended phase II dose of the combination of guadecitabine and durvalumab; the objective response rate for the combination of guadecitabine and durvalumab in hepatocellular carcinoma, pancreatic cancer, and cholangiocarcinoma cohorts
Principal Investigator: Anthony El-Khoueiry, USC Norris Comprehensive Cancer Center; contact Marile Garcia, RN, (323) 865-0967, Marile.GarciaLeiva@med.usc.edu
ClinicalTrials.gov Identifier: NCT03257761
Study Title: Phase I/IB Multicenter Study of Irreversible EGFR/HER2 Tyrosine Kinase Inhibitor Afatinib (BIBW 2992) in Combination With Capecitabine for Advanced Solid Tumors and Pancreaticobiliary Cancers
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: University of Washington/National Cancer Institute
Purpose: To study the side effects and best dose of afatinib dimaleate when given together with capecitabine in treating patients with metastasized solid tumors, pancreatic cancer, or biliary cancer that usually cannot be cured or controlled with treatment and has not responded to previous treatment
Primary Outcome Measures: Evaluate the safety, maximum tolerated dose, and recommended phase II dose of afatinib dimaleate in combination with capecitabine in patients with advanced solid tumors and pancreaticobiliary cancers
Principal Investigator: Elena Chiorean, Fred Hutch/University of Washington Cancer Consortium; contact (206) 288-6248, gchiorea@uw.edu
ClinicalTrials.gov Identifier: NCT02451553
PHASE II
Study Title: A Phase II Study of Pembrolizumab, a Monoclonal Antibody Against PD-1, in Combination With Capecitabine and Oxaliplatin in Subjects With Advanced Biliary Tract Carcinoma
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To study whether pembrolizumab given with capecitabine and oxaliplatin increases the time it takes for a person’s biliary tract cancer to progress
Primary Outcome Measures: The 5-month progression-free survival of pembrolizumab in combination with capecitabine and oxaliplatin in patients with advanced biliary tract carcinoma
Principal Investigator: Tim F. Greten, MD, National Cancer Institute; Suzanne Fioravanti, RN, (240) 760-6113, fioravas@mail.nih.gov
ClinicalTrials.gov Identifier: NCT03111732
Study Title: Phase II Trial of Pembrolizumab With GM-CSF Induction in Advanced Biliary Cancers
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: University of California, San Francisco
Purpose: To examine the efficacy and safety of a novel combination of pembrolizumab plus induction GM-CSF (granulocyte-macrophage colony-stimulating factor) in patients with advanced biliary cancers
Primary Outcome Measures: Overall response rate [time frame: start of treatment through date of discontinuation for up to 2 years]; Proportion of subjects with Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)—measurable disease at study entry who have a complete response or partial response (confirmed + unconfirmed) using RECIST 1.1 at any time during the main study
Principal Investigator: Robin Kate Kelley, MD, University of California, San Francisco; contact (877) 827-3222, cancertrials@ucsf.edu
ClinicalTrials.gov Identifier: NCT02703714
PHASE III
Study Title: A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers
Study Type: Interventional/parallel assignment
Study Sponsor and Collaborators: Southwest Oncology Group/National Cancer Institute
Purpose: To determine how well gemcitabine hydrochloride and cisplatin, given with or without nab-paclitaxel, work in treating patients with newly diagnosed metastasized biliary tract cancers
Primary Outcome Measures: To compare overall survival in patients with untreated, advanced biliary cancers treated with gemcitabine hydrochloride and cisplatin versus those treated with gemcitabine, cisplatin, and nab-paclitaxel
Principal Investigator: Rachna Shroff, Southwest Oncology Group; contact Danae Campos, (210) 614-8808 ext 1022, dcampos@swog.org, or Dana Sparks, (210) 614-8808 ext 1004, dsparks@swog.org
ClinicalTrials.gov Identifier: NCT03768414 ■
Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.
