Chemoembolization of the Liver With or Without Sunitinib Malate in Treating Patients With Liver Cancer
RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping anticancer drugs near the tumor. Sunitinib malate 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 chemoembolization is more effective with or without sunitinib malate in treating patients with liver cancer.
PURPOSE: This randomized phase II/III trial is studying the side effects of chemoembolization of the liver and to see how well in works when given together with or without sunitinib malate in treating patients with liver cancer.
Drug: sunitinib malate
Procedure: quality-of-life assessment
Procedure: transarterial chemoembolization
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Randomized, Phase II/III Study Comparing the Use of Chemoembolization Combined With Sunitinib Against Chemoembolization Combined With a Placebo in Patients With Hepatocellular Carcinoma (SATURNE)|
- Unacceptable bleeding or hepatic failure at 10 weeks post-treatment [ Designated as safety issue: Yes ]
- Overall survival [ Designated as safety issue: No ]
- Tumor stabilization rate [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
- Disease-free survival [ Designated as safety issue: No ]
- Relapse-free survival [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
- Overall survival rate at 2 years [ Designated as safety issue: No ]
|Study Start Date:||July 2010|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
- To evaluate unacceptable bleeding or hepatic failure at 10 weeks post-treatment in patients with unresectable hepatocellular carcinoma treated with transarterial chemoembolization in combination with sunitinib malate versus transarterial chemoembolization alone.
- To evaluate the overall survival of these patients.
- To evaluate the tumor stabilization rate in these patients.
- To evaluate the safety of this regimen in these patients.
- To evaluate the disease-free survival of these patients.
- To evaluate the relapse-free survival of these patients.
- To evaluate the quality of life of these patients.
- To evaluate the overall survival rate at 2 years of these patients.
OUTLINE: This is a multicenter study.
Pilot: Patients receive oral sunitinib malate once daily on days 1-28. Beginning 7-10 days later, patients undergo 1-3 courses of transarterial chemoembolization (TACE). Treatment repeats every 6 weeks for 1 year.
Randomization: Patients are stratified according to main tumor diameter (< 5 cm vs ≥ 5 cm), nodular involvement (uninodular vs multinodular), and center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive sunitinib malate and TACE as in the pilot phase.
- Arm II: Patients receive oral placebo once daily on days 1-28 and TACE as in the pilot phase.
Quality of life is assessed periodically.
|Centre Hospital Universitaire Hop Huriez||Recruiting|
|Lille, France, 59037|
|Contact: Contact Person 33-3-2044-5461 firstname.lastname@example.org|
|Paris, France, 75970|
|Contact: Contact Person 33-1-5601-6404 email@example.com|
|Institut Gustave Roussy||Recruiting|
|Villejuif, France, F-94805|
|Contact: Contact Person 33-1-4211-4339|
|Principal Investigator:||Mohamed Hebbar, MD||Centre Hospital Universitaire Hop Huriez|