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Hepatic ComplicationPhase 1NCT01888302

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

A Phase 1 study testing Cisplatin, Gemcitabine Hydrochloride and Quality-of-Life Assessment in people with Hepatic Complication, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatic Complication
What is being tested?
Cisplatin, Gemcitabine Hydrochloride and Quality-of-Life Assessment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
Sep 2013to Jun 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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®)
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  • 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
  • Phenobarbital (Luminal®)
  • Rifabutin (Mycobutin®)
  • Troglitazone
  • Any of the following prior therapies:
  • Chemotherapy =< 4 weeks prior to registration
  • Mitomycin C/nitrosoureas =< 6 weeks prior to registration
  • Immunotherapy =< 4 weeks prior to registration
  • Biologic therapy =< 4 weeks prior to registration
  • Radiation therapy =< 4 weeks prior to registration
  • Radiation to > 25% of bone marrow prior to registration
  • Failure to fully recover from acute, reversible effects of prior surgery or chemotherapy regardless of interval since last treatment
  • Any of the following because this study involves cytotoxic agents
  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation)
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive with low cluster of differentiation (CD)4 count; Note: previous calcineurin inhibitor or previous sirolimus use allowed
  • Current active other malignancy, except non-melanoma skin cancer or carcinoma-in-situ of the cervix; if there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer
  • Current impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of sirolimus (e.g., active ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
  • Current severely impaired lung function (i.e., forced expiratory volume in 1 second [FEV1] < 1 liter)
  • Received immunization with attenuated live vaccines =< 7 days prior to study entry or during study period; NOTE: Close contact with those who have received attenuated live vaccines should be avoided during treatment with sirolimus; examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, Bacillus Calmette-Guérin (BCG), yellow fever, varicella and typhoid (TY)21a typhoid vaccines
  • Current severe hepatic impairment; Note: A detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) ribonucleic acid (RNA) polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Pilot Trial of Sirolimus, Gemcitabine and Cisplatin for Patients With High Risk for Cholangiocarcinoma Recurrence

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Assessment of the percentage of patients who are able to complete therapy through 4 and 6 months post-registration.

SECONDARY OBJECTIVES:

  1. To describe the adverse events, rate of dose reductions, and quality of life in these patients.

II. To summarize timed endpoints of time-to-recurrence, disease-free survival, overall survival, time to treatment failure, and time until treatment related grade 3+ adverse events.

OUTLINE:

Patients receive cisplatin intravenously (IV) over 1 hour and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and sirolimus orally (PO) daily or three times weekly. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for up to 5 years.

Being tested
Cisplatin, Gemcitabine Hydrochloride, Quality-of-Life Assessment, Sirolimus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • Gemcitabine HydrochlorideDrug

    Also called dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemzar, LY-188011

    Given IV

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • SirolimusDrug

    Also called AY 22989, RAPA, Rapamune, RAPAMYCIN

    Given PO

Study groups in NCT01888302
Study groupRoleWhat they receive
Treatment (cisplatin, gemcitabine hydrochloride, sirolimus)ExperimentalPatients receive cisplatin IV over 1 hour and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and sirolimus PO daily or three times weekly. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Cisplatin; Drug: Gemcitabine Hydrochloride; Other: Quality-of-Life Assessment; Drug: Sirolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients who are able to complete therapy

    Measured: Up to 6 months post-registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01888302
Sponsor's protocol ID
MC1243
Other IDs
NCI-2013-01183, 12-007515, MC1243, P30CA015083
Status last verified
Feb 2016
First submitted
25 Jun 2013
Last updated
21 Jun 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cisplatin, Gemcitabine Hydrochloride and Quality-of-Life Assessment in people with Hepatic Complication, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients who are able to complete therapy (time frame: Up to 6 months post-registration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01888302.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2016.

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