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

Hepatic Complication Clinical Trial

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

Status Completed

Clinical 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. 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.

Clinical Trial Description

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

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.

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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Hepatic Complication

• NCT number: NCT01888302
• Study type: Interventional
• Source: Mayo Clinic
• Status: Completed
• Phase: Phase 1
• Start date: September 2013
• Completion date: June 2016