NCT01888302

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2013

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 21, 2016

Status Verified

February 1, 2016

Enrollment Period

2.8 years

First QC Date

June 25, 2013

Last Update Submit

June 20, 2016

Conditions

Hepatic Complication

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients who are able to complete therapy

    Up to 6 months post-registration

Study Arms (1)

Treatment (cisplatin, gemcitabine hydrochloride, sirolimus)

EXPERIMENTAL

Patients 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.

Drug: CisplatinDrug: Gemcitabine HydrochlorideOther: Quality-of-Life AssessmentDrug: Sirolimus

Interventions

CisplatinDRUG

Given IV

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin
Treatment (cisplatin, gemcitabine hydrochloride, sirolimus)
Gemcitabine HydrochlorideDRUG

Given IV

Also known as: dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemzar, LY-188011
Treatment (cisplatin, gemcitabine hydrochloride, sirolimus)
Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment
Treatment (cisplatin, gemcitabine hydrochloride, sirolimus)
SirolimusDRUG

Given PO

Also known as: AY 22989, RAPA, Rapamune, RAPAMYCIN, SILA 9268A, WY-090217
Treatment (cisplatin, gemcitabine hydrochloride, sirolimus)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +2 more criteria

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
  • +33 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Cisplatin1,2-diaminocyclohexaneplatinum II citratePlatinumGemcitabineSirolimus

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsMetals, HeavyElementsTransition ElementsMetalsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingMacrolidesLactonesOrganic Chemicals

Study Officials

  • Steven Alberts

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2013

First Posted

June 27, 2013

Study Start

September 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 21, 2016

Record last verified: 2016-02

Locations

US(1)