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Downstaging of Unresectable Intrahepatic or Hilar Cholangiocellular Carcinoma by Selective Intra-arterial Floxuridine and Systemic Cisplatin and Gemcitabine. A Dose Finding Single Center Phase IIa Study

Phase 1/Phase 2
18 Years
Open (Enrolling)
Cholangiocellular Carcinoma

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Trial Information

Downstaging of Unresectable Intrahepatic or Hilar Cholangiocellular Carcinoma by Selective Intra-arterial Floxuridine and Systemic Cisplatin and Gemcitabine. A Dose Finding Single Center Phase IIa Study

Inclusion Criteria

Inclusion criteria:

- Histologically or cytologically proven cholangiocellular carcinoma.

- Non-resectable cholangiocellular carcinoma as judged within an interdisciplinary
tumor-board including senior hepatobiliary surgeons. Non- resectability is based on
insufficient remnant liver volume.

- Patient is not a candidate for liver transplantation

- WHO Performance Score 0 or 1

- No extrahepatic tumor, as evaluated by PET/CT scan of the chest and the
abdomen/pelvis with the exception of potentially resectable small lung nodules or
hilar lymph node involvement.

- The assessment is done within 21 days before registration.

- Adequate liver function or kidney function tests, including any of the following:

- Bilirubin < 2 x ULN

- Aspartate-Aminotransferase (AST) < 5 x ULN

- Alanine-Aminotransferase (ALT) < 5 x ULN

- Alkaline phosphatase < 5 x ULN

- Estimated creatinine clearance > 60 ml/min (using the Cockcroft formula)

- Adequate hematological values:

- Hemoglobin > 80 G/L

- Leucocytes > 3.00 G/L,

- Neutrophils > 1.00 G/Ll

- Platelets > 100 G/L

- Adequate coagulation parameter: Quick > 40%

- Signed written informed consent

- Patient age >/= 18 years

- Presentation of the case at the interdisciplinary tumor-board attended by
hepatobiliary surgeons, oncologists, hepatologists and radiologists

- Women who are not breastfeeding and are using effective contraception if sexually
active, who are not pregnant and agree not to become pregnant during the 12 months
thereafter. A negative pregnancy test before inclusion into the trial is required for
women < 50 years.

- Men who agree not to father a child during participation in the trial or during the
12 months thereafter.

- Patient compliance and geographic proximity allow proper staging and follow- up.

Exclusion criteria:

- Anatomic variant in arteriogram which prevents selective delivery of the chemotherapy
to the liver

- Life expectancy < 3 months

- Severe medical or psychiatric co-morbidity prohibiting the planned treatment or the
giving of informed consent

- Any man or woman of childbearing age in case of inadequate contraception

- Pregnancy or breastfeeding woman

- Known hypersensitivity to trial drugs or hypersensitivity to any other component of
the trial drugs.

- Past or current use of other anti-cancer therapy

- Treatment in clinical trial within 30 days prior to trial entry.

- Oral anticoagulation and/or Quick = 40%

- Active heart disease defined as congestive heart failure > NYHA class 2

- Past or current history (within the last 2 years prior to treatment start) of other
malignancies except basal and squamous cell carcinoma of the skin or in situ
carcinoma of the cervix

- Inability or unwillingness to comply with the study protocol

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose limiting toxicities (DLT) of intravenous gemcitabine with concomitant administration of FUDR-HAI and intravenous cisplatin.

Outcome Description:

Dose limiting toxicities will be assessed to define the maximum tolerated dose (MTD) of gemcitabine in combination with fixed doses of cisplatin and FUDR. DLTs are per protocol prespecified AE or laboratory abnormalities observed during the first 6 weeks of study treatment. The MTD is one dose level below the dose level that caused DLTs in ≥ one third of patients (2 or more in a cohort of 6 patients), as determined by a traditional 3+3 algorithm.

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Panagiotis Samaras, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Zurich, Department of Oncology


Switzerland: Swissmedic

Study ID:




Start Date:

April 2012

Completion Date:

December 2013

Related Keywords:

  • Cholangiocellular Carcinoma
  • Carcinoma
  • Cholangiocarcinoma