Overview

This trial is active, not recruiting.

Condition liver cancer
Treatments sunitinib malate, placebo, transarterial chemoembolization
Phase phase 2/phase 3
Targets VEGF, FLT-3, KIT, PDGF
Sponsor Federation Francophone de Cancerologie Digestive
Start date July 2010
End date July 2018
Trial size 190 participants
Trial identifier NCT01164202, CDR0000681319, EU-21050, EUDRACT-2009-017064-16, FFCD-0905, FFCD-PRODIGE-16

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
placebo 3cps/days 4 weeks over 6 during 1 year
placebo
placebo 3cps/days 4 weeks over 6 during 1 year
transarterial chemoembolization
Chimioembolisation
(Experimental)
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 treatement) during 1 year
sunitinib malate
placebo 3cps/days 4 weeks over 6 during 1 year
transarterial chemoembolization
Chimioembolisation

Primary Outcomes

Measure
Occurrence of severe bleeding or liver failure
time frame: during the week following each TACE
Overall survival
time frame: 2 years

Secondary Outcomes

Measure
Toxicities
time frame: From Inclusion
Disease-free survival
time frame: From Inclusion

Eligibility Criteria

Male or female participants from 18 years up to 120 years old.

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

Additional Information

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)
Principal investigator Mohamed Hebbar, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Federation Francophone de Cancerologie Digestive.