Cediranib Maleate in Treating Patients With Locally Advanced or Metastatic Liver Cancer
Completed · Phase 2
Conditions studied: Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer
In brief
AZD2171 (cediranib maleate) 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. This phase II trial is studying how well AZD2171 works in treating patients with locally advanced or metastatic liver cancer.
Key facts
- Study ID
- NCT00238394
- Run by
- National Cancer Institute (NCI)
- People needed
- 44
- Starts
- 2005-12-01
- Last updated by the study team
- 2013-06-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- North Central Cancer Treatment Group — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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