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

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federation Francophone de Cancerologie Digestive
• Treatments: Sunitinib

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