A Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given with Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine (Standard of Care) alone in Patients with Intrahepatic Cholangiocarcinoma

Study Name
A Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given with Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine (Standard of Care) alone in Patients with Intrahepatic Cholangiocarcinoma
ClinicalTrials.gov Identifier (if applicable)
NCT03086993
Clinical Trial Category (check all that apply)
  • Chemotherapy
  • First Line Therapy
  • Targeted Therapy
Study Center
Institution Name
Duke University Medical Center
Institution Address
30 Duke Medicine Circle
City
Durham
State
North Carolina
Zip Code
27710
Study Contacts
Principal Investigator
Sabino Zani
P.I. Phone
(919) 684-6553
P.I. Email
sabino.zani@duke.edu
Study Coordinator
Kimberly Turnage
Study Coordinator Phone
(919) 681-5559
Study Coordinator Email
kimberly.turnage@duke.edu
OVERVIEW – in layman’s terms (150 words max)
Patients with intrahepatic cholangiocarcinoma who enroll in this study will receive either Melphalan with the investigational Hepatic Delivery System (called Melphalan/HDS) or Cisplatin and Gemcitabine alone, which is standard of care.  Patients who enroll will receive gem/cis followed by melphalan, compared to gem/cis.
Enrollment
5 at Duke, 295 nationally
Study Start Date
04/16/2018
Estimated Completion Date
04/16/2020
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • The main purpose of this study is to determine the safety and effectiveness of the Melphalan/Hepatic Delivery System (HDS) on treating intrahepatic cholangiocarcinoma.
Inclusion Criteria – Patients Must:
  • Have intrahepatic cholangiocarcinoma (ICC) which is unresectable and at least one large tumor
  • Be age 18 years or older, not pregnant, and weigh more than 77 pounds
Exclusion Criteria – Patients Must NOT:
  • Have more than 1/2 the liver affected by cancer, history of liver transplant or poor veins
  • Have insensitivity to melphalan, cisplatin, gemcitabine or similar compounds or severe allergic reactions to iodine contrast or latex
  • Have had prior treatment with gemcitabine or received an investigational drug within 30 days
  • Have had prior radiation to the liver
  • Have current uncontrolled illnesses, diseases, infections or other cancers
  • Have low blood counts
  • Be pregnant or unwilling/unable to be on birth control (men and women)
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
  • Medical history including medications, physical exam including vital signs
  • Electrocardiogram and Echocardiogram
  • CT scan and angiogram (x-ray and dye to look at blood flow)
  • Blood and urine tests including pregnancy test
  • CT scan of chest, abdomen, pelvis and CT of the liver
  • MRI (magnetic resonance imaging) of your liver
  • Bone scan
  • MRA (magnetic resonance angiogram) of the abdomen
POTENTIAL SIDE-EFFECTS – in layman’s terms
  • The Hepatic Delivery System of catheters and filters may cause side effects during the procedure or within several days after the procedure including a greater risk of bleeding during and after the study procedure. This can be severe. The filters also remove chemicals from your blood that control blood pressure.
  • Melphalan commonly causes side effects related to the blood and the liver. Low blood counts that could lead to infection, bruising and bleeding may occur and increases in liver enzymes, a sign of liver damage, may occur.
  • The most common side-effects seen in subjects treated with Cisplatin are decreased white blood cells, (the cells that fight infection), bruising, bleeding due to decrease in platelets (cells that help you clot), anemia (low number or red blood cells), feeling sick, tastes changes, loss of appetite, hair loss, tiredness, changes in the way your kidneys work, and numbness or tingling in your hands or feet.
  • The most common side-effects seen in subjects treated with Gemcitabine are decreased white blood cells, (the cells that fight infection), bruising, bleeding due to decrease in platelets (cells that help you clot), anemia (low number or red blood cells), feeling sick, loss of appetite, breathlessness, skin changes (skin is dry), hair loss, and tiredness.
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