Clinical Trials

It is not the intention of the Cholangiocarcinoma Foundation to provide specific medical advice.  We provide website users with information to help them better understand their health conditions and the current approaches related to prevention, diagnosis, treatment and supportive care. You are urged to always seek the advice of your physician or other qualified healthcare provider.

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: mailto:mvsahai@med.umich.eduail

Project Manager: Carolyn Andrews, RN
Project Manager Phone: 267-207-4070
Project Manager E-mail: mailto:mcandrews@precogllc.orgail

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.

Screen Shot 2014-04-27 at 6.35.52 PM

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.

Screen Shot 2014-04-27 at 6.36.09 PM

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.

Screen Shot 2014-04-27 at 6.36.22 PM

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.

Screen Shot 2014-04-27 at 6.43.51 PM

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.