Cediranib Maleate in Treating Patients With Locally Advanced or Metastatic Liver Cancer
Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer
About this trial
This is an interventional treatment trial for Adult Primary Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed hepatocellular carcinoma Locally advanced or metastatic disease Not amenable to treatment with surgery or orthotopic liver transplantation Measurable or non-measurable disease Measurable disease is defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan Evidence of disease progression by imaging on serial exams or biochemical evidence of a rising alpha fetoprotein on serial testing No history of brain metastases other than locally treatable CNS lesions (i.e., lesions treatable with surgery or radiosurgery) Patients with locally treatable CNS disease eligible provided they were previously treated and had no evidence of CNS progression for ≥ 4 weeks after completion of treatment No fibrolamellar hepatocellular carcinoma or mixed cholangiocarcinoma/hepatocellular carcinoma Performance status - ECOG 0-1 Absolute neutrophil count ≥ 1,200/mm^3 Platelet count ≥ 75,000/mm^3 Hemoglobin ≥ 10.0 g/dL Bilirubin ≤ 3 times upper limit of normal (ULN) AST ≤ 5 times ULN Alkaline phosphatase ≤ 5 times ULN Urine protein < 1+ by urine dip stick OR proteinuria < 1 gm/24-hour collection QTc prolongation ≤ 500 msec No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No uncontrolled blood pressure, defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg No significant ECG abnormality within the past 14 days No New York Heart Association class III or IV disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No history of allergic reaction to compounds of similar chemical or biological composition to AZD2171 No ongoing or active infection No psychiatric illness or social situation that would preclude study participation No other uncontrolled illness More than 4 weeks since prior biologic therapy More than 4 weeks since prior and no concurrent immunotherapy No colony-stimulating factors during the first course of study treatment At least 6 weeks since prior chemoembolization Patients must have evidence of disease progression or new metastases after prior chemoembolization No prior systemic chemotherapy for this cancer No other concurrent chemotherapy More than 4 weeks since prior hormonal therapy See Disease Characteristics At least 6 weeks since prior radiofrequency ablation or other local ablative therapy Patients must have evidence of disease progression or new metastases after prior radiofrequency ablation or other local ablative therapy No prior external beam radiotherapy to the primary site No prior radiotherapy to ≥ 25% of the bone marrow No concurrent radiotherapy See Disease Characteristics No concurrent combination antiretroviral therapy for HIV-positive patients No concurrent drugs or biologics with proarrhythmic potential
Sites / Locations
- North Central Cancer Treatment Group
Arms of the Study
Arm 1
Experimental
Treatment (cediranib maleate)
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a CR receive 2 additional courses beyond CR. Patients experiencing disease progression within 5 years after completion of study treatment may receive additional courses of study treatment.