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

Liver Cancer Clinical Trial

— SATURNE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01164202
• Other study ID #: PRODIGE 16
• Secondary ID: FFCD-PRODIGE-16F
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 2010
• Est. completion date: July 2017

Study information

• Verified date: March 2022
• Source: Federation Francophone de Cancerologie Digestive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed hepatocellular carcinoma or liver tumor responding to the Barcelona criteria

• Child-Pugh score of 5-6 (Class A)

• Tumor suitable for transarterial chemoembolization (one or more planned courses allowed)

• Tumor not suitable for surgical resection

• No extrahepatic metastases, including cerebral metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Absolute neutrophil count = 1.5 x 10^9/L

• Platelet count = 100 x 10^9/L

• Hemoglobin = 10 g/dL

• PT = 50%

• Creatinine = 120 µmol/L

• Bilirubin normal

• ALT/AST = 3.5 times upper limit of normal (ULN)

• Alkaline phosphatases = 4 times ULN

• Fibrinogen = 1.5 g/L

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No portal vein thrombosis

• Able to comply with scheduled follow-up and management of toxicity

• No uncontrolled hypertension or requiring = 2 classes of antihypertensive drugs

• No concomitant disease or uncontrolled severe disease

• No contraindications to the vascular occlusion procedure

• No prior or concurrent malignancy within the past 5 years, except adequately treated cone-biopsied carcinoma in situ of the cervix or basal cell carcinoma of the skin

• No psychiatric disability or social, family, or geographic reason for which the patient may not be followed regularly

PRIOR CONCURRENT THERAPY:

• At least 7 days since prior CYP3A4 inhibitors or inducers

• At least 3 months since prior radiofrequency ablation

• No prior chemotherapy

• No prior sunitinib, sorafenib, or any other inhibitors of angiogenesis

• No concurrent participation in another trial

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• sunitinib malate
placebo 3cps/days 4 weeks over 6 during 1 year
• Placebo
placebo 3cps/days 4 weeks over 6 during 1 year

Procedure:
• transarterial chemoembolization
Chimioembolisation

Locations

Country	Name	City	State
France	CHU Nord	Amiens
France	CHR	Annecy
France	Institut Sainte Catherine	Avignon
France	CHU J Minjoz	Besancon
France	CH	Béziers
France	Institut Bergonié	Bordeaux
France	CHU Côte de Nacre	Caen
France	CHU	Clermont Ferrand
France	Clinique des Cèdres	Cornebarrieu
France	CHU Bocage	Dijon
France	CH	Guilherand Granges
France	Hôpital Claude Huriez	Lille
France	Hopital Dupuytren	Limoges
France	CHBS	Lorient
France	Hôpital Privé Jean Mermoz	Lyon
France	CH Ambroise Paré	Marseille
France	CH Conception	Marseille
France	CHU La Timone	Marseille
France	Hôpital Saint Joseph	Marseille
France	CHRU Saint Eloi	Montpellier
France	CHU -Hôpital de l'Archet II	Nice
France	CHR	Orléans
France	Groupe Hospitalier Paris St Joseph	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Hopital Tenon	Paris
France	CHU Jean Bernard	Poitiers
France	CHU Robert Debré	Reims
France	CAC	Rennes
France	CHU	Rouen
France	CHU	Tours
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Federation Francophone de Cancerologie Digestive

Country where clinical trial is conducted

France, 

References & Publications (1)

Turpin A, de Baere T, Heurgué A, Le Malicot K, Ollivier-Hourmand I, Lecomte T, Perrier H, Vergniol J, Sefrioui D, Rinaldi Y, Edeline J, Jouve JL, Silvain C, Becouarn Y, Dauvois B, Baconnier M, Debette-Gratien M, Deplanque G, Dharancy S, Lepage C, Hebbar M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With Occurrence of Severe Bleeding and/or Liver Failure	The number of patients with at least one bleed and/or liver failure by treatment group	Up to 7 days following each TACE, up to 5 months of treatment
Secondary	Overall Survival	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.	From randomization until death or last news for alive patients, up to 3 years
Secondary	Disease-free Survival	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.	From randomization until the date of first progression (clinical or radiological) or death from any cause whichever came first