Clinical Trials

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STUDY NAME: Multicenter, Open-label, Randomized, Controlled Phase III Clinical Study of the Efficacy and Safety of Photodynamic Therapy Using Porfimer Sodium for Injection as Treatment for Unresectable Advanced Perihilar Cholangiocarcinoma

ClinicalTrials.gov Identifier: NCT02082522

STUDY CENTER:
A total of 40 centers in North America, Europe and Asia will participate. Please see ClinicalTrials.gov as sites are added.

United States, Arizona
Mayo Clinic Cancer Center
Scottsdale, Arizona, United States, 85259-5499
Contact: Clinical Trials Office - All Mayo Clinic Locations 855-776-0015 (toll free)

United States, California
University of Southern California Keck School of Medicine Recruiting
Los Angeles, California, United States, 90033-1026
Contact: Julie Ann Choudhury, MPH, CHES 323-865-3075 julie.choudhury@usc.edu
Principal Investigator: Jacques Van Dam, MD, Ph.D.

United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Sheryl Lynch, RN, CCRC 317-944-4228 slynch@iu.edu
Principal Investigator: Lee McHenry, MD

United States, Louisiana
Oschner Medical Center Recruiting
Kenner, Louisiana, United States, 70065
Contact: Casey Eichler, RN 504-842-8499 casey.eichler@ochsner.org
Principal Investigator: Virendra Joshi, MD

United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Joanne Dupuis, RN 313-916-8422 jdupuis3@hfhs.org
Principal Investigator: Cyrus Piraka, MD

United States, New York
Weill Cornell Medical College Not yet recruiting
New York, New York, United States, 10021
Contact: Monica Gaidhane, MD 646-962-4796 mog2012@med.cornell.edu
Principal Investigator: Michel Kahaleh, MD

United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Loranda Ross, RN 919-681-2941 loranda.ross@dm.duke.edu
Principal Investigator: M. Stanley Branch, MD

United States, Oklahoma
Southwestern Regional Medical Center, Inc. Recruiting
Tulsa, Oklahoma, United States, 74133
Contact: Faye Biggs 918-286-5448 faye.biggs@ctca-hope.com
Principal Investigator: Leon Yoder, DO

United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Cindi Miller, RN 215-955-8108 cynthia.miller@jefferson.edu
Principal Investigator: David Loren, MD

University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kathleen J Bauer, RN 412-605-3919 kbauer@pitt.edu
Principal Investigator: Adam Slivka, MD

United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Emily DePue 843-876-0487 depue@musc.edu
Principal Investigator: Gregory A. Cote, MD, M.Sc.

United States, Texas
Methodist Dallas Medical Center Recruiting
Dallas, Texas, United States, 75208
Contact: Nancy L Rosales, CCRP 214-947-1284 NancyRosales@mhd.com
Principal Investigator: Paul R Tarnasky, MD

United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Sarah Ackermann, CCRC 206-341-1295 Sarah.Ackermann@virginiamason.org
Principal Investigator: Seng-Ian Gan, MD

Canada, Ontario
St. Michael’s Hospital
Toronto, Ontario, Canada, M5B 1W8
Contact: Maria Cirocco, RN 416-864-6060 X 2965 ciroccom@smh.ca
Principal Investigator: Paul Kortan, MD

Germany
Klinikum Ludwigsburg Recruiting
Ludwigsburg, Baden Wuerttemberg, Germany, 71640
Contact: Juliane Behn +497141- 99 94464 juliane.behn@kliniken-lb.de
Principal Investigator: Karel Caca, Prof Dr med

Klinikum Mannheim GmbH Recruiting
Mannheim, Baden Wuerttemberg, Germany, 68167
Contact: Ralf Jesenofsky, Dr rer. nat. +49 621 383-5982 ralf.jesenofsky@umm.de
Principal Investigator: Sebastian Belle, Dr. med.

Johann-Wolfgang-Goethe Universität Frankfurt Recruiting
Frankfurt, Hessen, Germany, 60590
Contact: Djula Gross 49 69 6301-5212 djula.gross@kgu.de
Principal Investigator: Jörg Trojan, Prof Dr med

Medizinische Hochschule Hannover Recruiting
Hannover, Niedersachsen, Germany, 30625
Contact: Daniela Oehlert 49 0176 1532 6760 oehlert.daniela@mh-hannover.de
Principal Investigator: Arndt Vogel, Prof Dr med

Universitaetsklinikum des Saarlandes Recruiting
Homburg / Saar, Saarland, Germany, 66421
Contact: Karen Schneider 49 6841 16 23577 karen.schneider@uks.eu
Principal Investigator: Frank Lammert, Prof Dr med

Korea, Republic of
Konkuk University Medical Center Recruiting
Seoul, Gwangjin-gu, Korea, Republic of, 143-729
Contact: Hye La Kim 82 10 3436 7003 nangilima22@hanmail.net
Principal Investigator: Young Koog Cheon, Prof.

Soonchunhyang University Bucheon Hospital Recruiting
Bucheon City, Gyeonggi-do, Korea, Republic of, 420-767
Contact: Sun Mi Kim 82 32 621 5079 b2067@schmc.ac.kr
Principal Investigator: Jong Ho Moon, Prof.

Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: SooJu Park 82 31 787 8216 r1275@snubh.org
Principal Investigator: Jin-Hyeok Hwang, Prof.

Severance Hospital, Yonsei University Health System Recruiting
Seoul, Seodaemun-gu, Korea, Republic of, 120-752
Contact: So Young Jung 82 2 2227 4156 maru0823@yuhs.ac
Principal Investigator: Seungmin Bang, Prof. MD,PhD

Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Ban Seok Lee 82 10 7479 7170 iamaflower@hanmail.net
Principal Investigator: Sang Hyub Lee, MD, PhD

STUDY CONTACT:
Michelle Depot, Ph.D.
514-971-9855
mdepot@concordiarx.com

OVERVIEW:
This research study will evaluate the efficacy and safety of Photodynamic Therapy with porfimer sodium administered with Standard Medical Care (SMC) compared to SMC alone on the overall survival time of patients with non-operable advanced cholangiocarcinoma, a rare cancer of the bile ducts.

Photodynamic therapy (PDT) is a combination of a drug, porfimer sodium (Photofrin), which is activated by a light from a laser that emits no heat. The activation of the drug is done by lighting the abnormal areas using a fiber optic device (very fine fiber like a fishing line that permits light transmission) inserted into a flexible tube with a light called cholangioscope for the bile duct. The light will activate the porfimer sodium concentrated in the abnormal tissue, leading to its destruction.

Enrollment: 200 patients across United States, Canada, South Korea, Germany, and Switzerland

Study Start Date: August 2014

Estimated Study Completion Date: December 2018

PURPOSE OF THE STUDY:

  • To evaluate the safety and efficacy of photodynamic therapy in advanced nonoperable bile duct cancer.

Required Tests: 

  • Endoscopic evaluation of the bile duct, CT scan and lab tests.

Potential Side Effects:

  • Sensitivity to natural light, temporary inflammation at site of treatment, other typical complications associated with endoscopic evaluation of the bile duct.

INCLUSION CRITERIA – Patients must:

  • Males or females aged 18 or older
  • Diagnosed with radiologically and biopsy or cytology confirmed inoperable perihilar cholangiocarcinoma Bismuth Tumor Stage III/IV
  • Non-menopausal or non-sterile female subjects of childbearing potential must have a negative serum beta-HCG and use a medically acceptable form of birth control
  • Able to sign an informed consent
EXCLUSION CRITERIA – Patients must:
  • Diagnostic of cholangiocarcinoma made more than 45 days prior to randomization
  • Cholangiocarcinoma with extra-hepatic metastasis or concurrent non-solid malignancy
  • Presence or history of other neoplasms (treated during the last five years prior to study entry) other than carcinoma in situ of the cervix or basal carcinoma of the skin
  • Previously received photodynamic therapy for cholangiocarcinoma
  • Previously undergone surgical resection of the cholangiocarcinoma
  • Previously undergone chemotherapy, brachytherapy, or radiotherapy prior to entering the study
  • Previously undergone metal stent insertion
  • Porphyria or hypersensitivity to porphyrins (constituents of porfimer sodium), gemcitabine, cisplatin or other platinum-containing compounds
  • Presence of infection other than the infection of the bile duct (cholangitis)
  • Acute or chronic medical or psychological illnesses that prevent endoscopy procedures
  • Abnormal blood test results
  • Severe impairment of your kidney or liver function
  • Very advanced cirrhosis
  • Pregnant or intend to become pregnant, breastfeeding or intend to breast-feed during this study
  • Participated in another drug study within 90 days before this one
  • Unable or unwilling to complete the follow-up evaluations required for the study
PLEASE DOWNLOAD, PRINT AND CONSULT WITH TREATING PHYSICIAN
STUDY NAME: Study of Low-Dose Radiation Therapy to the Whole Liver in Combination with Gemcitabine and Cisplatin in Intrahepatic Cholangiocarcinoma

ClinicalTrials.gov Identifier: NCT02254681

STUDY CENTER:
Virginia Piper Cancer Institute
800 East 28th Street, Suite 602
Minneapolis, MN 55407
Phone: 612-863-7553

STUDY CONTACTS:
Principal Investigator: Srinevas K. Reddy, MD
PI Phone: 612-863-7553
PI E-Mail:
srinevas.reddy@allina.com

Study Coordinator:
Laura Rockwell, RN
Study Coordinator Phone:
612-863-9466
Study Coordinator E-mail:
laura.rockwell@allina.com

OVERVIEW:
In this Phase II study, researchers want to determine whether lower dose radiation therapy improves the response derived from chemotherapy for intrahepatic cholangiocarcinoma by combining chemotherapy treatment with low dose radiation therapy to the entire liver and adjacent lymph nodes.  Patients with surgically treatable or untreatable disease, and those with disease confined to or outside the liver are eligible for this study. Patients will have 4 cycles of treatment with each cycle lasting 3 weeks. All patients receive the same treatment. Medical history, physical examination and bloodwork are required.

Enrollment: 45 patients

Study Start Date: 9/25/2014

Estimated Study Completion Date: 01/30/2020

PURPOSE OF THE STUDY:

  1. Determine if the combination of low-dose radiation and chemotherapy results in a better treatment response and longer duration of response compared to that observed with chemotherapy alone
  2. Determine if the safety of combined low-dose radiation therapy and chemotherapy treatment is substantially different from that of chemotherapy alone
  3. Determine if low-dose radiotherapy alters the safety of liver surgery for those patients who are candidates for surgery after combined low-dose radiation therapy and chemotherapy treatment
INCLUSION CRITERIA – Patients must:
  1. Have satisfactory heart, lung, and kidney functions to tolerate chemotherapy treatment, and
  2. Have satisfactory blood test results, and
  3. Be either fully active or able to walk with assistance
EXCLUSION CRITERIA – Patients must:
  1. NOT have had prior chemotherapy, surgery, or radiation for intrahepatic cholangiocarcinoma
  2. NOT have had prior or current diagnoses of cirrhosis, primary sclerosing cholangitis hepatitis viral infections
  3. NOT be pregnant or unwilling to use adequate contraception (women)
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT
  • MRI of the abdomen
  • CT scan of the chest
  • Basic laboratory work
POTENTIAL SIDE-EFFECTS
  • Gemcitabine: Flu-like symptoms such as fever, fatigue, muscle aches, headache, cough, and mild nausea/vomiting are common. If a decrease in blood counts occur—the dose of chemotherapy will be adjusted in these cases.
  • Cisplatin: Flu-like symptoms such as fever, fatigue, muscle aches, headache, cough, and mild nausea/vomiting are common. A decrease in kidney function may occur—giving fluids and reducing in the dose of chemotherapy usually corrects this problem.
  • Radiation: Injury to surrounding structures such as stomach, small intestine, kidney, and spinal cord is possible. However, due to precise direction of the radiation combined with the very low doses used in this study, the likelihood of these side effects are low.
PLEASE DOWNLOAD, PRINT AND CONSULT WITH TREATING PHYSICIAN
STUDY NAME: PrE0204 - A Multi-Institutional, Single Arm, Two-Stage Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients with Advanced or Metastatic Cholangiocarcinoma (CCA)

ClinicalTrials.gov Identifier: NCT02181634

STUDY CENTERS:
A total of 20 US centers will participate. Please see ClinicalTrials.gov as sites are added.

United States, Colorado
Colorado Cancer Research Program
Denver, Colorado, United States, 80222
Contact: Patty Gibson 303-777-2663 pgibson@co-cancerresearch.org

United States, Iowa
Siouxland Hematology-Oncology Associates
Sioux City, Iowa, United States, 51101
Contact: Laura Martin 712-252-9329 martinl@shoa-research.org
Contact: Patty Skorey-Solberg 712-252-9358 solbe

United States, Louisiana
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
Contact: Socea May 504-842-2373 smay@ochsner.org
Contact: Shana Lennard 504-842-4498 slennard@ochsner.org

United States, Massachusetts
University Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Contact: Courtney Coughlin 508-856-2023 Courtney.Coughlin@umassmemorial.org
Contact: Barbara Butler, RN 508-856-1956 Barbara.Butler@umassmemorial.org

United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Contact: Courtney Wolf 734-936-9238 cowolf@umich.edu
Contact: Deb Krease 734-764-6847 debraakr@med.umich.edu

United States, Minnesota
Metro Minnesota CCOP
St. Louis Park, Minnesota, United States, 55416
Contact: Betsy Wagner 952-993-1555 elizabeth.wagner@parknicollet.com

United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
Contact: Elaine Keung 718-405-8344 ekeung@montefiore.org
Contact: Joel Victor 718-320-6680 jvictor@montefiore.org

United States, Tennessee
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Contact: Shanna Overbey, RN 865-305-5281 soverbey@utmck.edu
Contact: Patti Jones 865-305-9773 pcjones@utmck.edu

United States, Tennessee
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Contact: Shaunita Michael 615-343-0798 shaunita.a.michael@vanderbilt.edu
Contact: Marquita Hill 615-875-3260 marquita.j.haywood@vanderbilt.edu

United States, Wisconsin
Gundersen Health System
La Crosse, Wisconsin, United States, 54601
Contact: Debbie Kettner-Sieber 608-775-1195 dlkettne@gundersenhealth.org
Contact: Nancy Fisher 608-775-2733 nrfisher@gundersonhealth.org

United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792
Contact: Carissa Amundson 608-265-1181 camund@uwcarbone.wisc.edu
Contact: Elizabeth Mikula 608-263-2901 ermikula@uwcarbone.wisc.edu

United States, Wisconsin
Aurora Cancer Care
Wauwatosa and Green Bay, Wisconsin, United States, 53226
Contact: Kate Newbanks 920-288-4115 Kate.Newbanks@aurora.org
Contact: Patti Allard 414-778-4346 Patti.Allard@aurora.org

STUDY CONTACTS:
Study Chair: Vaibhav Sahai, MD
Study Chair E-Mail: vsahai@med.umich.edu

Project Manager: Carolyn Andrews, RN
Project Manager Phone: 267-207-4070
Project Manager E-mail: candrews@precogllc.org

OVERVIEW:
In this Phase II study, researchers want to evaluate the effectiveness and safety of the combination of nab-paclitaxel and gemcitabine. The effectiveness will be determined by improvement in the length of time during and after treatment, that the cholangiocarcinoma does not get worse. Patients with advanced or metastatic cholangiocarcinoma who are not eligible for curative surgery, transplantation, or ablative therapies will receive nab-paclitaxel and gemcitabine chemotherapy. Patients will receive treatment until the cancer gets worse or spreads. All patients receive the same treatment. Medical history, physical examination, blood work, and a tumor tissue sample are required.

ENROLLMENT:
Stage I will enroll 37 patients. If 21 or more patients are progression-free at 6 months, the study will proceed to Stage II and an additional 33 patients will be enrolled.

STUDY START DATE:
9/17/2014

ESTIMATED STUDY COMPLETION DATE:
4/15/2017

PURPOSE OF THE STUDY:

  1. Determine the effectiveness of gemcitabine and nab-paclitaxel in patients with advanced cholangiocarcinoma
  2. Describe the safety and toxicity of the combination of nab-paclitaxel and gemcitabine in patients with advanced cholangiocarcinoma

INCLUSION CRITERIA – Patients must:

  1. Have a histologically-confirmed diagnosis of cholangiocarcinoma American Joint Committee on Cancer (AJCC) Stage II, III, or IV cholangiocarcinoma (intra-hepatic, extra-hepatic and perihilar) that is not eligible for curative resection, transplantation, or ablative therapies. Tumors of mixed histology are not allowed.
  2. May have received prior radiation, chemoembolization, radioembolization, or other local ablative therapies, or hepatic resection if completed ≥ 4 weeks prior to registration
  3. Have satisfactory heart, lung, and kidney functions to tolerate chemotherapy treatment, and
  4. Have satisfactory blood test results, and
  5. Be either fully active or able to walk with assistance

EXCLUSION CRITERIA – Patients must:

  1. NOT have received prior systemic cytotoxic chemotherapy or targeted therapy for this cancer.
  2. NOT  be receiving immunosuppressive medications, including systemic corticosteroids, aside from the following exceptions: used for adrenal replacement, appetite stimulation, acute therapy for asthma or bronchitis (≤ 2 weeks), or anti-nausea/vomiting
  3. NOT be pregnant or unwilling to use adequate contraception (women)

REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT:

  1. MRI or CT scan of the abdomen/pelvic, with contrast
  2. CT scan of the chest, with contrast
  3. Basic laboratory work
  4. Consent to storage of a tumor tissue sample

OPTIONAL TESTS:

  1. Research blood specimens to evaluate for circulating tumor cells

POTENTIAL SIDE-EFFECTS:

  1. Gemcitabine: Flu-like symptoms such as fever, fatigue, muscle aches, headache, cough, and mild nausea/vomiting are common. If a decrease in blood counts occur—the dose of chemotherapy will be adjusted.
  2. Nab-Paclitaxel: Decrease in red blood cells, white blood cells, and platelets, and mild nausea/vomiting are common. A disorder of the nerves which can cause tingling or numbness, with weakness, or decreased sensation or movement may occur.

PLEASE PRINT AND CONSULT WITH TREATING PHYSICIAN


A list of current clinical trials from the National Cancer Institute.

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Video: Participating in a Clinical Trial

This eight minute video features the stories of two clinical research volunteers who provide a personal perspective into the clinical research process.  Also in the video are interviews with their family members who offer insight into what it’s like when a loved one is undergoing experimental treatment.

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Smart Talking about Clinical Studies

This engaging webpage is designed to provide a brief introduction to clinical trials with interactive videos that provide patients with important information about taking part in a clinical trial.  You will also find useful information about clinical trials in general and a glossary with definitions of research phrases and terms.

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Why They Chose to be Research Volunteers

This video shares the stories of several trial participants including their perspectives and the motivations behind their decision to take part in clinical research.

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Clinical Trials 101

In 2010, Dr. Jack Welch from the National Cancer Institute (NCI), joined gave a presentation to the Cholangiocarcinoma Foundation and our community, the purpose of his webinar was to discuss some clinical trial basics and to answer some frequently asked questions.