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NCT04891289 | RECRUITING | Intrahepatic Cholangiocarcinoma

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

Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease

Intrahepatic Cholangiocarcinoma

Intervention/treatment

Gemcitabine

Oxaliplatin

Dexamethasone

Floxuridine (FUDR)

Implanted Medical Device

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 164 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Randomized Phase II Study of Systemic Chemotherapy With or Without HAI FUDR/Dexamethasone in Patients With Unresectable Intrahepatic Cholangiocarcinoma
Actual Study Start Date : 2021-05-07
Estimated Primary Completion Date : 2025-05
Estimated Study Completion Date : 2025-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery

Location Details

NCT04891289

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Maryland

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

Bethesda, Maryland, United States, 20824

RECRUITING

United States, Missouri

Washington University (Data Collection Only)

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities

Basking Ridge, New Jersey, United States, 07920

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Monmouth - Limited Protocol Activities

Middletown, New Jersey, United States, 07748

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Bergen - Limited Protocol Activities

Montvale, New Jersey, United States, 07645

RECRUITING

United States, New York

Memorial Sloan Kettering Commack - Limited Protocol Activities

Commack, New York, United States, 11725

RECRUITING

United States, New York

Memorial Sloan Kettering Westchester - Limited Protocol Activities

Harrison, New York, United States, 10604

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

RECRUITING

United States, New York

Memorial Sloan Kettering Nassau - Limited Protocol Activities

Uniondale, New York, United States, 11553

NOT YET RECRUITING

United States, North Carolina

Duke University (Data Collection Only)

Durham, North Carolina, United States, 27710

RECRUITING

Netherlands,

Erasmus University (Data Collection Only)

Rotterdam, Netherlands, 3015 GD