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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier:
NCT01164202
First received: July 15, 2010
Last updated: August 2, 2016
Last verified: August 2016
  Purpose

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.


Condition Intervention Phase
Liver Cancer
Drug: sunitinib malate
Drug: Placebo
Procedure: transarterial chemoembolization
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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)

Resource links provided by NLM:


Further study details as provided by Federation Francophone de Cancerologie Digestive:

Primary Outcome Measures:
  • Occurrence of severe bleeding or liver failure [ Time Frame: during the week following each TACE ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicities [ Time Frame: From Inclusion ] [ Designated as safety issue: Yes ]
  • Disease-free survival [ Time Frame: From Inclusion ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: July 2010
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
placebo 3cps/days 4 weeks over 6 during 1 year
Drug: Placebo
placebo 3cps/days 4 weeks over 6 during 1 year
Procedure: transarterial chemoembolization
Chimioembolisation
Experimental: Sunitinib
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
Drug: sunitinib malate
placebo 3cps/days 4 weeks over 6 during 1 year
Procedure: transarterial chemoembolization
Chimioembolisation

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.

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164202

Locations
France
CHU Nord
Amiens, France
CHR
Annecy, France
Institut Sainte Catherine
Avignon, France
CHU J Minjoz
Besancon, France
CH
Bezier, 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, 59037
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
Hopital Tenon
Paris, France, 75970
Groupe Hospitalier Paris St Joseph
Paris, France
Hôpital Européen Georges Pompidou
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, France
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Investigators
Principal Investigator: Mohamed Hebbar, MD Centre Hospital Universitaire Hop Huriez
  More Information

Additional Information:
Responsible Party: Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier: NCT01164202     History of Changes
Other Study ID Numbers: CDR0000681319  FFCD-PRODIGE-16  FFCD-0905  EUDRACT-2009-017064-16  EU-21050 
Study First Received: July 15, 2010
Last Updated: August 2, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Federation Francophone de Cancerologie Digestive:
adult primary hepatocellular carcinoma
localized unresectable adult primary liver cancer
advanced adult primary liver cancer

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 28, 2016