Study Name
A Phase II study of induction systemic mFOLFIRINOX followed by hepatic arterial infusion of Floxuridine and Dexamethasone given concurrently with systemic mFOLFIRI as a first-line therapy in patients with unresectable liver-dominant intrahepatic cholangiocarcinoma
ClinicalTrials.gov Identifier (if applicable)
NCT04251715
Clinical Trial Category (check all that apply)
  • First Line Therapy
Study Center
Institution Name
Knight Cancer Institute at Oregon Health & Science University
Institution Address
3485 SW Bond Ave
City
Portland
State
Oregon
Zip Code
97239
Country
United States
Website
https://apps.ohsu.edu/research/study-participation-opportunitiessystem/listing.php?hcat=Adult+Cancers&cat=Gastrointestinal+Cancers
List additional Institutions (include address, phone number, and website)
NA
Study Contacts
Principal Investigator
Dr. Skye C. Mayo, MD, MPH, FACS
P.I. Phone
(503) 494-5501
P.I. Email
GIResearch@ohsu.edu
Study Coordinator
Erin Taber
Study Coordinator Phone
(503) 418-9642
Study Coordinator Email
GIResearch@ohsu.edu
OVERVIEW – in layman’s terms (150 words max)
This clinical trial is for patients with intrahepatic cholangiocarcinoma that is not able to be removed by surgery. This study utilizes the combination of HAI pump therapy and intravenous chemotherapy. The purpose of this study is to test chemotherapy treatment combined with HAI pump therapy to find out how effective it is for patients.
Enrollment
30, with a 6 patient initial safety-run
Study Start Date
09/01/2020
Estimated Completion Date
09/01/2024
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • o Seeking to validate our theory that the combination of induction mFOLFIRINOX followed by mFOLFIRI and HAI therapy for intrahepatic cholangiocarcinoma will work well allowing the liver disease to be controlled and in some cases be changed from unresectable to resectable.
Inclusion Criteria – Patients Must:
  • Liver-dominant ICC, must comprise <70% of the liver parenchyma, as defined by CT liver segmental volumetrics
  • Disease must be considered technically unresectable or be multifocal in the liver at the time of preoperative evaluation
  • ECOG 0 or 1 status (Karnofsky ≥ 60)
  • WBC ≥ 3000 cells/mm3
  • ANC ≥ 1500 cells/mm3
  • Platelet count ≥ 100,000 / mm3
  • INR ≤ 1.5
  • Creatinine within normal institutional limits OR creatinine clearance ≥ 60 ml/min/1.73 m2 for participants with creatinine levels above institutional limits
  • Total bilirubin < 1.5 mg/dL
  • AST (SGOT)/ALT(SGPT) ≤ 2.5 x institutional ULN
Exclusion Criteria – Patients Must NOT:
  • Presence of extensive or multifocal metastatic extrahepatic or peritoneal disease.
  • Prior treatment with floxuridine, oxaliplatin, or irinotecan
  • Prior external beam radiation therapy to the liver or hepatic arterial or venous delivery of internal radiation therapy such as Y-90.
  • Current biliary obstruction requiring placement of endoscopic or transhepatic stents for biliary decompression
  • Pregnant or lactating women.
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
  • Review of medical history
  • Review of any medications you are taking
  • Physical exam
  • Vital signs (blood pressure, heart rate, and temperature), weight, and height
  • Performance status evaluation (what type of daily activities you can do)
  • Electrocardiogram (ECG)
  • Research blood tests—approximately 1 tablespoon or 15 mL
  • Routine blood tests – approximately 2 tablespoons or 29 mL of blood to check your blood counts (numbers of each type of blood cell), chemistries (elements and minerals in your blood), and how well your organs are functioning, and Hepatitis B or C test to determine if you have, or have had, Hepatitis B or C.
  • Pregnancy Test (if needed)
  • If the urine pregnancy test is positive, serum pregnancy tests must be performed
  • Computed Tomography (CT) scan and/or Magnetic Resonance Imaging (MRI) and/or Positronic Emission Tomography (PET) of your tumor
  • Women who can become pregnant must have a negative pregnancy test before a CT or PET scan is performed.
  • Diffuse Weighted‐MRI (DW‐MRI) to help the investigator see the liver tumors and better assess response to treatment
  • CT Angiography (CTA) to examine the structure of blood vessels in your liver to make sure you can receive the HAI pump
  • Laparoscopy to assess your tumor (outpatient procedure that will be done at the same time as the Mediport placement below)
  • Questionnaires and interviews
  • Mediport placement
  • Provide tumor tissue, archival or biopsy
  • Counseling
  • Evaluation to assess support, financial stability, and drug and alcohol use
POTENTIAL SIDE-EFFECTS – in layman’s terms
  • Stomach ulcer
  • Bleeding
  • Intestinal upset that may include inflammation of the intestines causing diarrhea, cramps, nausea, vomiting, and fever
  • Inflammation of the tongue
  • Sore throat -inflammation of pharynx and/or tonsils
  • Loss of appetite
  • Cramps
  • Pain in belly
  • Scarring/hardening of the bile duct tissue (biliary sclerosis)
  • Hair loss
  • Yellow of skin called “jaundice” as a result of bile duct scarring
  • Skin rash (dermatitis)
  • Muscle pain or weakness
  • Fatigue
  • Headache
  • Swelling (edema)
  • Confusion or mood changes
  • High blood sugar (hyperglycemia)
  • Weight gain
  • Vision Changes
  • Sleep problems (insomnia)
  • Skin changes (hair growth, acne, slow wound healing, rash)