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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)


Phase 2
21 Years
N/A
Open (Enrolling)
Both
Intrahepatic Cholangiocarcinoma, Peripheral Cholangiocarcinoma, Cholangiolar Carcinoma, Cholangiocellular Carcinoma

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Trial Information

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)


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 must be obtained.

- 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 ≥ 3,000 cells/mm3

- Platelet count ≥ 100,000/mm3

- Creatinine ≤ 1.8 mg/dl

- Total bilirubin < 1.6 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 preor postoperative biopsies that definitively diagnose ICC, the diagnostic
studies may be modified at the discretion of the 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)

- Active infection

- Pregnant or lactating women

- History of other malignancy within the past 5 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

- History of disease progression on gemcitabine and oxaliplatin

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression free survival

Outcome Description:

Treatment evaluation will be done using RECIST (version 1.1)

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

William Jarnagin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

13-066

NCT ID:

NCT01862315

Start Date:

May 2013

Completion Date:

May 2016

Related Keywords:

  • Intrahepatic Cholangiocarcinoma
  • Peripheral Cholangiocarcinoma
  • Cholangiolar Carcinoma
  • Cholangiocellular Carcinoma
  • Hepatic Arterial Infusion (HAI)
  • Floxuridine (FUDR)
  • Dexamethasone (DEX)
  • Gemcitabine
  • Oxaliplatin
  • 13-066
  • Carcinoma
  • Cholangiocarcinoma
  • Liver Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021