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Trial Title:
Hepatic Arterial Infusion (HAI) With Floxuridine (FUDR) and Dexamethasone (Dex) Combined With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma (ICC)
NCT ID:
NCT01862315
Condition:
Intrahepatic Cholangiocarcinoma
Peripheral Cholangiocarcinoma
Cholangiolar Carcinoma
Cholangiocellular Carcinoma
Conditions: Official terms:
Carcinoma
Cholangiocarcinoma
Dexamethasone
Gemcitabine
Oxaliplatin
Floxuridine
Conditions: Keywords:
Hepatic Arterial Infusion (HAI)
Floxuridine (FUDR)
Dexamethasone (DEX)
Gemcitabine
Oxaliplatin
13-066
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Floxuridine (FUDR)
Arm group label:
No prior chemo or responded/stable with prior chemo
Arm group label:
patients who have failed systemic therapy
Intervention type:
Drug
Intervention name:
dexamethasone
Arm group label:
No prior chemo or responded/stable with prior chemo
Arm group label:
patients who have failed systemic therapy
Arm group label:
pts who have had prior oxaliplatin & have existing neuropathy
Intervention type:
Drug
Intervention name:
Gemcitabine
Arm group label:
No prior chemo or responded/stable with prior chemo
Arm group label:
patients who have failed systemic therapy
Arm group label:
pts who have had prior oxaliplatin & have existing neuropathy
Intervention type:
Drug
Intervention name:
Oxaliplatin
Arm group label:
No prior chemo or responded/stable with prior chemo
Arm group label:
patients who have failed systemic therapy
Intervention type:
Other
Intervention name:
MRI
Arm group label:
No prior chemo or responded/stable with prior chemo
Arm group label:
patients who have failed systemic therapy
Arm group label:
pts who have had prior oxaliplatin & have existing neuropathy
Intervention type:
Other
Intervention name:
Research blood draws
Description:
These are optional
Arm group label:
No prior chemo or responded/stable with prior chemo
Arm group label:
patients who have failed systemic therapy
Arm group label:
pts who have had prior oxaliplatin & have existing neuropathy
Summary:
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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
Basking Ridge
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Monmouth
Address:
City:
Middletown
Zip:
07748
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Commack
Address:
City:
Commack
Zip:
11725
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Westchester
Address:
City:
Harrison
Zip:
10604
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Nassau
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Start date:
May 2013
Completion date:
May 2025
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01862315
http://www.mskcc.org/