Hepatic Arterial Infusion (HAI) With Floxuridine (FUDR) and Dexamethasone (Dex) Combined With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma (ICC)

Status:	Active, not recruiting
Conditions:	Liver Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	21 - Any
Updated:	3/29/2019
Start Date:	May 2013
End Date:	May 2020

A Phase II Study of Hepatic Arterial Infusion (HAI) With Floxuridine (FUDR) and Dexamethasone (Dex) Combined With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma (ICC)

The purpose of this study is to use both, liver pump treatment and systemic chemotherapy, to
assess the effects this type of treatment has on the patient and the tumor. Liver pump
treatment uses a metal pump that is surgically placed in the abdomen and gives chemotherapy
directly to the liver. Systemic chemotherapy gives chemotherapy through a vein [intravenously
(IV)] and treats the whole body. This type of treatment has been done before and had shown
that people with both pump and systemic chemotherapy had improved results. The investigators
hope that this combination of treatments improves the response to chemotherapy and reduces
the spread of the disease.

Another purpose of this study is to learn the clinical importance of a specific type of MRI
scan. The investigators would like to see if this type of MRI will help predict the response
to the treatment and see if they could help the physician with their treatment plan. These
scans will be done at specific time points.

The last purpose of this study is to learn more about how the tumor interacts with the
chemotherapy. This will be done through a biopsy taken during surgery and blood draws at
specific time points.

Permission from patients entering the study will be obtained to take normal and tumor liver
biopsies at the time of surgery. These samples are voluntary and optional.

Inclusion Criteria:

- Age ≥ 21 years

- Histologically confirmed intrahepatic cholangiocarcinoma (also variously reported as
peripheral cholangiocarcinoma, cholangiolar carcinoma or cholangiocellular carcinoma)
(ICC). Confirmation of the diagnosis at MSKCC or at the enrolling institution must be
obtained prior to initiation of protocol therapy.

- Clinical or radiographic evidence of metastatic disease to regional lymph nodes will
be allowed, provided it is amenable to resection.

- Radiographically measurable disease. Measurable disease is defined as disease that can
be assessed with 2-dimensional measurements on a cross-sectional imaging. Minimum
lesion size is 2cm in greatest diameter as per RECIST criteria.

- Disease must be considered unresectable at the time of preoperative evaluation.

- Presence of less than 70% liver involvement by cancer.

- Patients may have failed ablative therapy

- Patient previously treated with systemic chemotherapy will be eligible

- KPS ≥ 60% and be considered candidates for general anesthesia, abdominal exploration
and hepatic artery pump placement

- Patients with chronic hepatitis and/or cirrhosis are eligible, but must be Child-Pugh
class A

- Patients must be able to read, understand and sign informed consent

- WBC ≥ 2,000 cells/mm3

- Platelet count ≥ 75,000/mm3

- Creatinine ≤ 1.8 mg/dl

- Total bilirubin < 1.5 mg/dl

Exclusion Criteria:

- Presence of distant metastatic disease. Patients will undergo radiographic evaluation
to exclude the possibility of distant metastatic disease. For patients who have
undergone pre- or postoperative biopsies that definitively diagnose ICC, the
diagnostic studies may be modified at the discretion of the MSKCC Principal
Investigator. Clinical or radiographic evidence of metastatic disease to regional
lymph nodes will be allowed, provided it is amenable to resection.

- Prior treatment with FUDR

- Prior external beam radiation therapy to the liver

- Diagnosis of sclerosing cholangitis

- Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal
vein thrombosis) surgically related ascites does not exclude the patient)

- Active infection

- Pregnant or lactating women

- History of other malignancy within the past 3 years (except non-melanoma skin cancer)

- Life expectancy less than 12 weeks

- Inability to comply with study and/or followup procedures

- History of peripheral neuropathy (Note: this does not apply to Cohort 3)

We found this trial at

sites

Memorial Sloan Kettering Cancer Center

1275 York Ave
New York, New York 10021

(212) 639-2000