A Phase I Open Label/Phase II Randomized, Double-Blind, Multicenter Trial Investigating the Combination of Everolimus and TransArterial ChemoEmbolization (TACE) With Doxorubicin in Patients With Hepatocellular Carcinoma

NCT01009801 Phase 1/Phase 2 TERMINATED

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoembolization kills tumor cells by carrying drugs directly into the tumor and blocking the blood flow to the tumor. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether transarterial chemoembolization with doxorubicin is more effective when given alone or when given together with everolimus in treating patients with liver cancer. PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of everolimus when given together with transarterial chemoembolization with doxorubicin and to see how well it works compared with giving transarterial chemoembolization with doxorubicin alone in treating patients with liver cancer.

Details

Lead sponsor	Swiss Cancer Institute
Phase	Phase 1/Phase 2
Status	TERMINATED
Enrolment	27
Start date	2010-02
Completion	2015-06

Conditions

• Liver Cancer

Interventions

• doxorubicin-eluting beads
• everolimus
• placebo

Primary outcomes

• Dose-limiting toxicity (Phase I) — after 6 weeks from registration
  Dose limiting toxicity (DLT) (observed within the first TACE period)
• Time to progression (Phase II) — 12 weeks after randomisation

Countries

Switzerland