Chemoembolization of the Liver With or Without Sunitinib Malate in Treating Patients With Liver Cancer

Phase 2

Completed

Interventions: Drug: Placebo
Drug: sunitinib malate
Procedure: transarterial chemoembolization

Brief Summary: 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.

Detailed Description: OBJECTIVES:

Primary

* 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.

Secondary

* 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Placebo	transarterial chemoembolization	placebo 3cps/days 4 weeks over 6 during 1 year
Sunitinib	transarterial chemoembolization	sunitinib (SUTENT®) 37,5 mg/d (3 cps of 12,5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year
Placebo	Placebo	placebo 3cps/days 4 weeks over 6 during 1 year
Sunitinib	sunitinib malate	sunitinib (SUTENT®) 37,5 mg/d (3 cps of 12,5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Occurrence of Severe Bleeding and/or Liver Failure	Up to 7 days following each TACE, up to 5 months of treatment	The number of patients with at least one bleed and/or liver failure by treatment group

Secondary Outcome Measures

Name	Time	Method
Overall Survival	From randomization until death or last news for alive patients, up to 3 years	Overall survival is defined as the time from the date of randomization to the date of death (from any cause). Patients lost to follow-up or alive at the time of analysis are censored at the last news date or the point date. This time is used to calculate the median follow-up time.
Disease-free Survival	From randomization until the date of first progression (clinical or radiological) or death from any cause whichever came first	Disease-free survival is defined as the time interval between randomization and local or distant relapse or second cancer or death (all causes). Alive patients are censored at the last follow-up.

Locations (27): CHU Nord
🇫🇷
Amiens, France
CHR
🇫🇷
Orléans, France
Institut Sainte Catherine
🇫🇷
Avignon, France
CHU J Minjoz
🇫🇷
Besancon, France
Institut Bergonié
🇫🇷
Bordeaux, France
CH
🇫🇷
Guilherand Granges, France
CHU Côte de Nacre
🇫🇷
Caen, France
CHU
🇫🇷
Tours, France
Clinique des Cèdres
🇫🇷
Cornebarrieu, France
CHU Bocage
🇫🇷
Dijon, France
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CHU Nord
🇫🇷Amiens, France