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AZD2171 in Treating Patients With Locally Advanced Unresectable or Metastatic Liver Cancer - NCT00427973-02115(Clinical Trial 161180)



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City:  Boston
State:  
MA
Zip Code: 02115
Conditions: Liver Cancer
Purpose: RATIONALE: AZD2171 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 AZD2171 works in treating patients with locally advanced unresectable or metastatic liver cancer.
Study summary: OBJECTIVES: Primary - Assess the progression free survival of patients with locally advanced unresectable or metastatic hepatocellular carcinoma treated with AZD2171. Secondary - Determine the toxicity of this drug in these patients. - Determine, preliminarily, the efficacy of this drug, in terms of response rate, duration of response, and overall survival, in these patients. - Determine the blood flow changes and vascular permeability of the tumor in patients treated with this drug. - Determine the pharmacokinetic profile of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Dynamic contrast-enhanced (DCE) MRI and CT perfusion scan of the liver are performed at baseline, 72 hours after the initial dose of AZD2171, and at the end of course 1. Blood samples for pharmacokinetic studies are collected periodically during study. After the completion of study treatment, patients are followed every 3 months for 1 year. PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.
Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed hepatocellular carcinoma - Locally advanced unresectable OR metastatic disease - Cancer of the Liver Italian Program (CLIP) score ≤ 3 - Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan - Measurable lesion must be outside field of prior chemoembolization - No known brain metastases PATIENT CHARACTERISTICS: - ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% - Life expectancy > 12 weeks - Absolute neutrophil count ≥ 1,000/mm³ - Platelet count ≥ 75,000/mm³ - Hemoglobin ≥ 8 g/dL - Bilirubin ≤ 3.0 mg/dL - AST and ALT ≤ 7 times upper limit of normal - Creatinine ≤ 2.0 mg/dL - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - CLIP score ≤ 3 - No history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD2171 - No chronic diarrhea or any disorder that would limit adequate absorption of AZD2171 - No mean QTc > 470 msec (with Bazett's correction) on screening EKG (490 msec for women) - No familial history of long QT syndrome - Proteinuria ≤ +1 on two consecutive dipsticks taken no less than 1 week apart - No other uncontrolled illness including, but not limited to, any of the following: - Hypertension - Ongoing or active infection - Symptomatic congestive heart failure - Unstable angina pectoris - Cardiac arrhythmia - No psychiatric illness or social situation that would limit study compliance PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Recovered from prior therapy - Prior systemic chemotherapy regimens for hepatocellular carcinoma allowed - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) - More than 4 weeks since prior radiotherapy, major surgery, or chemoembolization - At least 30 days since prior participation in an investigational trial - No other concurrent investigational agents - No concurrent medication that may markedly affect renal function (e.g., vancomycin, amphotericin, or pentamidine) - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent anticancer agents or therapies
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Data Source: ClinicalTrials.gov
Date Processed: June 22, 2010
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