Sunitinib in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Sunitinib 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.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with liver cancer that cannot be removed by surgery.

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

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Treatments: Sunitinib

Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

• Histologically, cytologically, or radiologically confirmed hepatocellular carcinoma (HCC) meeting 1 of the following criteria:

• Localized, surgically unresectable disease

• Candidates for radical surgery for locally advanced disease are excluded

• Metastatic disease

• Measurable disease, defined as ≥ 1 lesion, outside of pretreated areas, that can be measured in ≥ 1 dimension as ≥ 10 mm by spiral or multi-slice CT scan or MRI

• Child-Pugh class A or mildly decompensated Child-Pugh class B liver dysfunction

Exclusion criteria:

• Clinical ascites of any grade

• Clinical symptoms or history of CNS metastases or leptomeningeal disease

• Known fibrolamellar HCC or mixed cholangiocarcinoma and HCC

PATIENT CHARACTERISTICS:

Inclusion criteria:

• WHO performance status 0-1

• Hemoglobin ≥ 9.0 g/dL

• Absolute neutrophil count ≥ 1,500/mm³

• Platelet count ≥ 75,000/mm³

• Bilirubin ≤ 2 times upper limit of normal (ULN)

• ALT ≤ 7 times ULN

• Albumin ≥ 2.5 g/dL

• Creatinine clearance ≥ 40 mL/min

• Quick test ≥ 50% (adequate coagulation)

• Urine dipstick for proteinuria < 2+ OR ≤ 1 g of protein in 24-hour urine collection

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 12 months after completion of study therapy

Exclusion criteria:

• Pregnant or nursing

• Encephalopathy

• Malignancy within the past 5 years except for adequately treated cervical carcinoma in situ or localized nonmelanoma skin cancer

• Hemorrhagic or thrombotic cerebrovascular event in the past 12 months

• Documented variceal hemorrhage within the past 3 months

• History or presence of clinically significant acute or unstable cardiovascular, cerebrovascular, renal, gastrointestinal, pulmonary, immunological (except for the presence of hepatitis B virus, hepatitis C virus, or cirrhosis), endocrine, or central nervous system disorders

• Known HIV infection

• Active infection requiring IV antibiotics

• Arterial hypertension ≥ 150/100 mm Hg, despite therapy

• Ongoing cardiac dysrhythmias ≥ grade 2

• Atrial fibrillation of any grade

• Prolongation of QTc > 500 msec in screening ECG or history of familial long QT syndrome

• Inability to take oral medications

• Psychiatric disorder precluding understanding of information of study-related topics, giving informed consent, or interfering with compliance for oral drug intake

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

• At least 4 weeks since prior surgery or liver-directed therapy (e.g., transarterial embolization/chemoembolization [limited to 5 treatments], radiofrequency ablation, cryoablation, radiotherapy, or percutaneous ethanol injection)

• Previously treated lesions must remain separate from those to be measured in the present study

• Low-dose anticoagulants for maintenance of patency of central venous access or prevention of deep vein thrombosis allowed

Exclusion criteria:

• Prior systemic anticancer treatment for hepatocellular carcinoma

• Prior organ transplantation

• Treatment in a clinical study within the past 30 days

• Concurrent full-dose anticoagulant or requirement for anticoagulant therapy

• Concurrent experimental drugs or other anticancer therapy

• Concurrent use or anticipated need for CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, voriconazole, erythromycin, clarithromycin, and protease inhibitors)

• Concurrent CYP3A4 inducers (e.g., carbamazepine, continuous treatment with dexamethasone [> 2 mg/day for > 7 days], phenobarbital, phenytoin, rifampicin, and St John's wort)

• Concurrent antacids allowed provided they are administered > 1 hour before or > 1 hour after study drug

• Concurrent elective major surgery

• Concurrent radiotherapy

• Concurrent analgesic radiotherapy of nontarget lesions allowed