Sirolimus, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients At High Risk for Cholangiocarcinoma Recurrence After Liver Transplant or Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01888302|
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : June 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hepatic Complication||Drug: Cisplatin Drug: Gemcitabine Hydrochloride Other: Quality-of-Life Assessment Drug: Sirolimus||Phase 1|
I. Assessment of the percentage of patients who are able to complete therapy through 4 and 6 months post-registration.
I. 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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Trial of Sirolimus, Gemcitabine and Cisplatin for Patients With High Risk for Cholangiocarcinoma Recurrence|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Treatment (cisplatin, gemcitabine hydrochloride, sirolimus)
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: Gemcitabine Hydrochloride
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
- Percentage of patients who are able to complete therapy [ Time Frame: Up to 6 months post-registration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888302
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Steven Alberts||Mayo Clinic|