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

NCT01164202 | Completed Phase 2 Results

• 5 other identifiers: PRODIGE 16FFCD-PRODIGE-16FFCD-0905EUDRACT-2009-017064-16EU-21050
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 31

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.

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinoma; localized unresectable adult primary liver cancer; advanced adult primary liver cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall Survival

  From randomization until death or last news for alive patients, up to 3 years

• Disease-free Survival

  From randomization until the date of first progression (clinical or radiological) or death from any cause whichever came first

Study Arms (2)

Placebo

PLACEBO COMPARATOR

placebo 3cps/days 4 weeks over 6 during 1 year

Drug: Placebo; Procedure: transarterial chemoembolization

Sunitinib

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 treatment) during 1 year

Drug: sunitinib malate; Procedure: transarterial chemoembolization

Interventions

sunitinib malate DRUG

placebo 3cps/days 4 weeks over 6 during 1 year

Sunitinib

Placebo DRUG

placebo 3cps/days 4 weeks over 6 during 1 year

Placebo

transarterial chemoembolization PROCEDURE

Chimioembolisation

Placebo; Sunitinib

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Federation Francophone de Cancerologie Digestive: lead

Study Sites (31)

CHU Nord

Amiens, France

Location

CHR

Annecy, France

Location

Institut Sainte Catherine

Avignon, France

Location

CHU J Minjoz

Besançon, France

Location

CH

Béziers, France

Location

Institut Bergonié

Bordeaux, France

Location

CHU Côte de Nacre

Caen, France

Location

CHU

Clermont-Ferrand, France

Location

Clinique des Cèdres

Cornebarrieu, France

Location

CHU Bocage

Dijon, France

Location

CH

Guilherand-Granges, France

Location

Hôpital Claude Huriez

Lille, 59037, France

Location

Hopital Dupuytren

Limoges, France

Location

CHBS

Lorient, France

Location

Hôpital Privé Jean Mermoz

Lyon, France

Location

CH Ambroise Paré

Marseille, France

Location

CH Conception

Marseille, France

Location

CHU La Timone

Marseille, France

Location

Hôpital Saint Joseph

Marseille, France

Location

CHRU Saint Eloi

Montpellier, France

Location

CHU -Hôpital de l'Archet II

Nice, France

Location

CHR

Orléans, France

Location

Hopital Tenon

Paris, 75970, France

Location

Groupe Hospitalier Paris St Joseph

Paris, France

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

CHU Jean Bernard

Poitiers, France

Location

CHU Robert Debré

Reims, France

Location

CAC

Rennes, France

Location

CHU

Rouen, France

Location

CHU

Tours, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Related Publications (1)

• Turpin A, de Baere T, Heurgue 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; PRODIGE 16 investigators Collaborators. Liver transarterial chemoembolization and sunitinib for unresectable hepatocellular carcinoma: Results of the PRODIGE 16 study. Clin Res Hepatol Gastroenterol. 2021 Mar;45(2):101464. doi: 10.1016/j.clinre.2020.05.012. Epub 2020 Jun 21.

  PMID: 32576496 RESULT

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Mrs Karine Le Malicot
• Organization: FFCD

karine.le-malicot@u-bourgogne.fr

+33 3 80 39 34 79

Study Officials

• Mohamed Hebbar, MD

  Centre Hospital Universitaire Hop Huriez

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2010
• First Posted: July 16, 2010
• Study Start: July 1, 2010
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: March 18, 2022
• Results First Posted: March 18, 2022

Record last verified: 2022-03

Locations

FR (31)