RECRUITING

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

Conditions

Intrahepatic Cholangiocarcinoma Gemcitabine Oxaliplatin Floxuridine Dexamethasone Pump 20-348

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-05-07

Study Completion:2025-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04891289

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Andrea Cercek, MD

CONTACT

646-888-4189

cerceka@mskcc.org

William Jarnagin, MD

CONTACT

212-639-7601

Principal Investigator

Andrea Cercek, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

National Heart, Lung, and Blood Institute (NIH) (Data Collection Only)

Bethesda, Maryland, 20824

United States

Washington University (Data Collection Only)

Saint Louis, Missouri, 63110

United States

Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth - Limited Protocol Activities

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen - Limited Protocol Activities

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Commack - Limited Protocol Activities

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester - Limited Protocol Activities

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau - Limited Protocol Activities

Uniondale, New York, 11553

United States

Duke University (Data Collection Only)

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Andrea Cercek, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-07

Study Completion Date2025-05

Study Record Updates

Study Start Date2021-05-07

Study Completion Date2025-05

Terms related to this study

Keywords Provided by Researchers

Gemcitabine
Oxaliplatin
Floxuridine
Dexamethasone Pump
20-348

Additional Relevant MeSH Terms

Intrahepatic Cholangiocarcinoma