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, Florida, Minnesota
Mayo Clinic Cancer Center
Contact: Clinical Trials Office
All Mayo Clinic Locations 855-776-0015 (toll-free)

California
UC Davis Medical Center
Sacramento, California 95817
Principal Investigator: Shiro Urayama, MD
Contact: Lisa A Wilson
Phone: 916-903-9198
Email: lawilson@ucdavis.edu

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

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

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

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

North Carolina
Duke University Medical Center
Durham, North Carolina 27710
Principal Investigator: M. Stanley Branch, MD
Phone: 919-681-2941
Email: loranda.ross@dm.duke.edu

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

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

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

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

Texas
Methodist Dallas Medical Center
Dallas, Texas 75208
Principal Investigator: Paul R Tarnasky, MD
Contact: Nancy L Rosales, CCRP
Phone: 214-947-1284
Email: nancyrosales@mhd.com

Washington
Virginia Mason Medical Center
Seattle, Washington 98101
Principal Investigator: Seng-Ian Gan, MD
Contact: Sarah Ackermann, CCRC
Phone: 206-341-1295
Email: sarah.ackermann@virginiamason.org

Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States, 99204
Contact: Tracy Roundy, BS
Phone: 509-474-3823
Email: tracy.roundy@providence.org
Principal Investigator: Wichit Srikureja, MD

Canada

St. Michael’s Hospital
Toronto, Ontario M5B 1W8
Principal Investigator: Paul Kortan, MD
Contact: Maria Cirocco, RN 
Phone: 416-864-6060 x2965 
Email: ciroccom@smh.ca

Germany

Frankfurt
Johann-Wolfgang-Goethe Universität Frankfurt
Frankfurt, Hessen 60590
Principal Investigator: Prof Dr med Jörg Trojan
Contact: Djula Gross, Pharm
Phone: 49 69 630 15212
Email: djula.gross@kgu.de

Hannover
Medizinische Hochschule Hannover
Hannover, Niedersachsen 30625
Principal Investigator: Arndt Vogel, Prof Dr med
Contact: Daniela Oehlert, BA (nursing)
Phone: 49 01 765 326760
Email: oehlert.daniela@mh-hannover.de

Homburg
Universitaetsklinikum des Saarlandes
Homburg/Saar, Saarland 66421
Principal Investigator: Frank Lammert, Prof Dr med
Contact: Karen Schneider
Phone: 49 68 411 623577
Email: karen.schneider@uks.eu

Ludwigsburg
Klinikum Ludwigsburg
Ludwigsburg, Baden Wuerttemberg 71640
Principal Investigator: Karel Caca, Prof Dr med
Contact: Juliane Behn
Phone: 49 71 419 994464
Email: juliane.behn@kliniken-lb.de

Mannheim
Klinikum Mannheim GmbH
Mannheim, Baden Wuerttemberg 68167
Principal Investigator: Dr med Sebastian Belle
Contact: Dr rer. nat. Ralf Jesenofsky
Phone: 49 62 383 5982
Email: ralf.jesenofsky@umm.de

Korea, Republic of

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

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

Seoul
Konkuk University Medical Center
Seoul, Gwangjin-gu 143-729
Principal Investigator: Young Koog Cheon, Prof
Contact: Hye La Kim
Phone: 82 10 343 67003
Email: nangilima22@hanmail.net

Seoul National University Hospital
Seoul 110-744
Principal Investigator: Sang Hyub Lee, MD, PhD
Contact: Ban Seok Lee
Phone: 82 10 747 97170
Email: iamaflower@hanmail.net

Severance Hospital, Yonsei University Health System
Seoul, Seodaemun-gu 120-752
Principal Investigator: Seungmin Bang, Prof. MD, PhD
Contact: So Young Jung, RN
Phone: 82 22 227 4156
Email: maru0823@yuhs.ac

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, New York
Mount Sinai Hospital – the only participating site in Manhattan
New York City, New York, United States, 10029
Contact: Sofya Pintova 212-824-8858 Sofya.Pintova@mssm.edu

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


ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.

Search for term Cholangiocarcinoma

Search for term Bile Duct Cancer

Search for term Solid Tumor

 

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, Florida, Minnesota
Mayo Clinic Cancer Center
Contact: Clinical Trials Office
All Mayo Clinic Locations 855-776-0015 (toll-free)

California
UC Davis Medical Center
Sacramento, California 95817
Principal Investigator: Shiro Urayama, MD
Contact: Lisa A Wilson
Phone: 916-903-9198
Email: lawilson@ucdavis.edu

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

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

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

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

North Carolina
Duke University Medical Center
Durham, North Carolina 27710
Principal Investigator: M. Stanley Branch, MD
Phone: 919-681-2941
Email: loranda.ross@dm.duke.edu

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

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

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

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

Texas
Methodist Dallas Medical Center
Dallas, Texas 75208
Principal Investigator: Paul R Tarnasky, MD
Contact: Nancy L Rosales, CCRP
Phone: 214-947-1284
Email: nancyrosales@mhd.com

Washington
Virginia Mason Medical Center
Seattle, Washington 98101
Principal Investigator: Seng-Ian Gan, MD
Contact: Sarah Ackermann, CCRC
Phone: 206-341-1295
Email: sarah.ackermann@virginiamason.org

Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States, 99204
Contact: Tracy Roundy, BS
Phone: 509-474-3823
Email: tracy.roundy@providence.org
Principal Investigator: Wichit Srikureja, MD

Canada

St. Michael’s Hospital
Toronto, Ontario M5B 1W8
Principal Investigator: Paul Kortan, MD
Contact: Maria Cirocco, RN 
Phone: 416-864-6060 x2965 
Email: ciroccom@smh.ca

Germany

Frankfurt
Johann-Wolfgang-Goethe Universität Frankfurt
Frankfurt, Hessen 60590
Principal Investigator: Prof Dr med Jörg Trojan
Contact: Djula Gross, Pharm
Phone: 49 69 630 15212
Email: djula.gross@kgu.de

Hannover
Medizinische Hochschule Hannover
Hannover, Niedersachsen 30625
Principal Investigator: Arndt Vogel, Prof Dr med
Contact: Daniela Oehlert, BA (nursing)
Phone: 49 01 765 326760
Email: oehlert.daniela@mh-hannover.de

Homburg
Universitaetsklinikum des Saarlandes
Homburg/Saar, Saarland 66421
Principal Investigator: Frank Lammert, Prof Dr med
Contact: Karen Schneider
Phone: 49 68 411 623577
Email: karen.schneider@uks.eu

Ludwigsburg
Klinikum Ludwigsburg
Ludwigsburg, Baden Wuerttemberg 71640
Principal Investigator: Karel Caca, Prof Dr med
Contact: Juliane Behn
Phone: 49 71 419 994464
Email: juliane.behn@kliniken-lb.de

Mannheim
Klinikum Mannheim GmbH
Mannheim, Baden Wuerttemberg 68167
Principal Investigator: Dr med Sebastian Belle
Contact: Dr rer. nat. Ralf Jesenofsky
Phone: 49 62 383 5982
Email: ralf.jesenofsky@umm.de

Korea, Republic of

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

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

Seoul
Konkuk University Medical Center
Seoul, Gwangjin-gu 143-729
Principal Investigator: Young Koog Cheon, Prof
Contact: Hye La Kim
Phone: 82 10 343 67003
Email: nangilima22@hanmail.net

Seoul National University Hospital
Seoul 110-744
Principal Investigator: Sang Hyub Lee, MD, PhD
Contact: Ban Seok Lee
Phone: 82 10 747 97170
Email: iamaflower@hanmail.net

Severance Hospital, Yonsei University Health System
Seoul, Seodaemun-gu 120-752
Principal Investigator: Seungmin Bang, Prof. MD, PhD
Contact: So Young Jung, RN
Phone: 82 22 227 4156
Email: maru0823@yuhs.ac

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
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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.
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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, New York
Mount Sinai Hospital – the only participating site in Manhattan
New York City, New York, United States, 10029
Contact: Sofya Pintova 212-824-8858 Sofya.Pintova@mssm.edu

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.

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