NCT01888302

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hepatic Complication

Interventions

Type	Name	Description
DRUG	Cisplatin	Given IV
DRUG	Gemcitabine Hydrochloride	Given IV
OTHER	Quality-of-Life Assessment	Ancillary studies
DRUG	Sirolimus	Given PO

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2013-06-27
• Last updated: 2016-06-21

Locations

1 site across 1 country: United States