Chemoembolization of the Liver With or Without Sunitinib Malate in Treating Patients With Liver Cancer
This study is currently recruiting participants.
Verified July 2010 by National Cancer Institute (NCI)
Sponsor:
Federation Francophone de Cancerologie Digestive
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01164202
First received: July 15, 2010
Last updated: July 24, 2010
Last verified: July 2010
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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 Procedure: quality-of-life assessment Procedure: transarterial chemoembolization |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind 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 National Cancer Institute (NCI):
Primary Outcome Measures:
- Unacceptable bleeding or hepatic failure at 10 weeks post-treatment [ Designated as safety issue: Yes ]
- Overall survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Tumor stabilization rate [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
- Disease-free survival [ Designated as safety issue: No ]
- Relapse-free survival [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
- Overall survival rate at 2 years [ Designated as safety issue: No ]
| Estimated Enrollment: | 190 |
| Study Start Date: | July 2010 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
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 and older |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164202
Locations
| France | |
| Centre Hospital Universitaire Hop Huriez | Recruiting |
| Lille, France, 59037 | |
| Contact: Contact Person 33-3-2044-5461 m-hebbar@chru-lille.fr | |
| Hopital Tenon | Recruiting |
| Paris, France, 75970 | |
| Contact: Contact Person 33-1-5601-6404 jean-didier.grange@tnn.aphp.fr | |
| Institut Gustave Roussy | Recruiting |
| Villejuif, France, F-94805 | |
| Contact: Contact Person 33-1-4211-4339 | |
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Investigators
| Principal Investigator: | Mohamed Hebbar, MD | Centre Hospital Universitaire Hop Huriez |
More Information
Additional Information:
No publications provided
| 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: | July 24, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
adult primary hepatocellular carcinoma localized unresectable adult primary liver cancer advanced adult primary liver cancer |
Additional relevant MeSH terms:
|
Liver Neoplasms Carcinoma, Hepatocellular Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Liver Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Sunitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013