Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:

A Randomized Phase II Study of Systemic Chemotherapy With or Without HAI FUDR/Dexamethasone in Patients With Unresectable Intrahepatic Cholangiocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04891289
• Other study ID #: 20-348
• Status: Recruiting
• Phase: Phase 2
• Start date: May 7, 2021
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Andrea Cercek, MD
• Phone: 646-888-4189
• Email: cerceka[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare the safety and effects of HAI floxuridine and dexamethasone combined with the standard chemotherapy drugs gemcitabine and oxaliplatin (GemOx) with those of GemOx alone in people with untreated cholangiocarcinoma that cannot be removed with surgery. The researchers want to find out whether the study treatment works better than the standard chemotherapy to delay progression of disease. For the study treatment to be considered better than the standard treatment, the study treatment should increase the time until progression of disease by an average of 3 months, compared with the usual approach.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years
• ECOG 0-1
• Histologically confirmed intrahepatic cholangiocarcinoma (also variously reported as peripheral cholangiocarcinoma, cholangiolar carcinoma or cholangiocellular carcinoma) (IHC). Confirmation of the diagnosis at MSKCC or at the enrolling institution must be obtained prior to randomization.
• Clinical or radiographic evidence of metastatic disease confined to the liver. Note:

presence of regional (porta hepatis) lymph node metastases will be allowed, provided they are amenable to resection. (Note: If peritoneal or other extrahepatic disease is found at time of pump placement, the pump will not be implanted. The patient will be removed from study, deemed nonevaluable and will not count toward the overall study accrual.)

• 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 2 cm in greatest diameter as per RECIST criteria.
• Disease must be considered unresectable at the time of preoperative evaluation.*
• Considered candidate 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.
• WBC = 2,000/mcL , ANC = 1000/mcL
• Platelet count = 75,000/mcL
• Creatinine = 1.8 mg/dL
• Total bilirubin < 1.5 mg/dL
• Hgb > 7 g/dL The % involvement of the liver will be determined by radiologists after review of imaging

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 post-operative biopsies that definitively diagnose IHC, 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.
• Patients previously treated with systemic chemotherapy for IHC will be non-eligible.
• Prior treatment with FUDR.
• Prior external beam radiation therapy to the liver.
• Prior ablative 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 within one week prior to HAI placement.
• Pregnant or lactating women.
• History of other malignancy within the past 3 years except with early stage/localized cancer that was surgically resected or radiation treatment that would yield the same result as surgery within the past 3 years.
• Life expectancy <12 weeks.
• Inability to comply with study and/or follow-up procedures.
• History of peripheral neuropathy. There is no exclusion of patients based on sex, ethnicity or race. For these reasons, the study results are expected to be generalizable to the Medicare beneficiary population.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma

Intervention

Drug:
• Gemcitabine
See arm for details.
• Oxaliplatin
See arm for details.
• Dexamethasone
See arm for details.
• Floxuridine (FUDR)
See arm for details.

Device:
• Implanted Medical Device
Implanted hepatic arterial infusion pump by surgical oncology, to deliver HAI therapy

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities	Basking Ridge	New Jersey
United States	National Heart, Lung, and Blood Institute (NIH) (Data Collection Only)	Bethesda	Maryland
United States	Memorial Sloan Kettering Commack - Limited Protocol Activities	Commack	New York
United States	Duke University (Data Collection Only)	Durham	North Carolina
United States	Memorial Sloan Kettering Westchester - Limited Protocol Activities	Harrison	New York
United States	Memorial Sloan Kettering Monmouth - Limited Protocol Activities	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen - Limited Protocol Activities	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Washington University (Data Collection Only)	Saint Louis	Missouri
United States	Memorial Sloan Kettering Nassau - Limited Protocol Activities	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess progression-free survival (PFS)	will be done using RECIST (version 1.1).	2 years
Secondary	Overall survival (OS)		2 years

External Links

•   Memorial Sloan Kettering Cancer Center