Status:
COMPLETED
Cediranib Maleate in Treating Patients With Locally Advanced or Metastatic Liver Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the 6-month survival of patients with locally advanced or metastatic hepatocellular carcinoma treated with AZD2171. SECONDARY OBJECTIVES I. Determine tumor response ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00238394
Start Date
December 1 2005
Last Update
June 5 2013
Active Locations (1)
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1
North Central Cancer Treatment Group
Rochester, Minnesota, United States, 55905