Sirolimus, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients At High Risk for Cholangiocarcinoma Recurrence After Liver Transplant or Surgery

Completed · Phase 1

Conditions studied: Hepatic Complication

In brief

This pilot phase I trial studies the side effects and best way to give sirolimus, gemcitabine hydrochloride, and cisplatin in treating patients at high risk for cholangiocarcinoma recurrence after liver transplant or surgery. Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sirolimus with gemcitabine hydrochloride and cisplatin may prevent disease recurrence in patients with a high risk of recurrence after a liver transplant or surgery.

Key facts

Study ID

NCT01888302

Run by

Mayo Clinic

People needed

1

Starts

2013-09-01

Expected to finish

2016-06-01

Last updated by the study team

2016-06-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologic proof of presence of residual tumor in liver explants and /or positive resection margins
• Absolute neutrophil count (ANC) >= 1500/μL obtained =< 7 days prior to registration
• Platelets (PLT) >= 100,000/μL obtained =< 7 days prior to registration
• Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) obtained =< 7 days prior to registration
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN obtained =< 7 days prior to registration (=< 5 x ULN in patients with liver metastases)
• Creatinine =< 1.5 x Institutional ULN obtained =< 7 days prior to registration
• Alkaline phosphatase =< 5 x institutional ULN obtained =< 7 days prior to registration
• Hemoglobin (Hgb) >= 9.0 g/dL obtained =< 7 days prior to registration
• International normalized ratio (INR) and partial thromboplastin (PTT) =< 3.0 x ULN (anticoagulation is allowed if target INR =< 3.0 x ULN on a stable dose of warfarin or on a stable dose of low molecular weight [LMW] heparin for > 2 weeks at time of registration)
• Fasting serum glucose < 1.5 x ULN obtained =< 7 days prior to registration
• Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x ULN obtained =< 90 days prior to registration; NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
• Ability to provide informed consent
• Willingness to return to Mayo Clinic for follow up
• Life expectancy >= 12 months
• Women of childbearing potential only: negative serum pregnancy test done =< 7 days prior to registration
• Four months post liver transplant

You may not qualify if…

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Clinically significant cardiac disease, especially history of myocardial infarction =< 6 months, or congestive heart failure (New York Heart Association [NYHA] classification III or IV) requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
• Taking strong inhibitors or strong/moderate inducers of cytochrome P450 (CYP)3A4
• Strong inhibitors of CYP3A4/5; > 5-fold increase in the plasma area under the curve (AUC) values or more than 80% decrease in clearance
• Clarithromycin (Biaxin®, Biaxin XL®)
• Conivaptan (Vaprisol®)
• Grapefruit juice
• Itraconazole (Sporanox®)
• Ketoconazole (Nizoral®)
• Mibefradil
• Nefazodone (Serzone®)
• Posaconazole (Noxafil®)
• Telaprevir (Incivek®)
• Telithromycin (Ketek®)
• Use of the following inducers are prohibited =< 7 days prior to registration
• Strong inducers of CYP3A4/5; > 80% decrease in AUC
• Avasimibe
• Carbamazepine (Carbatrol®, Epitol®, Equetro™, Tegretol®, Tegretol-XR®)
• Phenytoin (Dilantin®, Phenytek®)
• Rifampin (Rifadin®)
• St. John's wort
• Moderate inducers of CYP3A4/5; 50-80% decrease in AUC
• Bosentan (Tracleer®)
• Modafinil (Provigil®)
• Nafcillin

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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