Status:
TERMINATED
AZD2171 in Treating Patients With Locally Advanced Unresectable 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
This phase II trial is studying how well AZD2171 works in treating patients with locally advanced unresectable or metastatic liver cancer. AZD2171 may stop the growth of tumor cells by blocking some o...
Detailed Description
PRIMARY OBJECTIVE: I. Assess the progression free survival of patients with locally advanced unresectable or metastatic hepatocellular carcinoma treated with AZD2171. SECONDARY OBJECTIVES: I. Deter...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed hepatocellular carcinoma
- Locally advanced unresectable OR metastatic disease
- Cancer of the Liver Italian Program (CLIP) score =\< 3
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Measurable disease, defined as \>= 1 unidimensionally measurable lesion\>= 20 mm by conventional techniques OR \>= 10 mm by spiral CT scan
- Cardiac arrhythmia
- Measurable lesion must be outside field of prior chemoembolization
- No known brain metastases
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Life expectancy \> 12 weeks
- Absolute neutrophil count \>= 1,000/mm\^3
- Platelet count \>= 75,000/mm\^3
- Hemoglobin \>= 8 g/dL
- Bilirubin =\< 3.0 mg/dL
- AST and ALT =\< 7 times upper limit of normal
- Creatinine =\< 2.0 mg/dL
- Fertile patients must use effective contraception
- CLIP score =\< 3
Exclusion
- Not pregnant or nursing
- Negative pregnancy test
- 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 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
- No psychiatric illness or social situation that would limit study compliance
- 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
- No mean QTc \> 470 msec (with Bazett's correction) on screening EKG (490 msec for women)
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00427973
Start Date
May 1 2009
End Date
March 1 2012
Last Update
October 31 2016
Active Locations (1)
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1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114