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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)


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
Liver Cancer

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Trial Information

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)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Unacceptable bleeding or hepatic failure at 10 weeks post-treatment

Safety Issue:

Yes

Principal Investigator

Mohamed Hebbar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospital Universitaire Hop Huriez

Authority:

Unspecified

Study ID:

CDR0000681319

NCT ID:

NCT01164202

Start Date:

July 2010

Completion Date:

Related Keywords:

  • Liver Cancer
  • adult primary hepatocellular carcinoma
  • localized unresectable adult primary liver cancer
  • advanced adult primary liver cancer
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

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