AZD2171 in Treating Patients With Locally Advanced Unresectable or Metastatic Liver Cancer
This study has been terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00427973
First received: January 25, 2007
Last updated: March 13, 2013
Last verified: March 2013
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Purpose
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 of the enzymes needed for cell growth and by blocking blood flow to the tumor
| Condition | Intervention | Phase |
|---|---|---|
|
Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer |
Drug: cediranib maleate Other: laboratory biomarker analysis Procedure: computed tomography Procedure: dynamic contrast-enhanced magnetic resonance imaging Other: pharmacological study |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of AZD2171 in Hepatocellular Carcinoma |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Progression-free survival [ Time Frame: 3 months ] [ Designated as safety issue: No ]This design yields at least 90% power to detect a true 3-month PFS rate of at least 69%.
Secondary Outcome Measures:
- Response rate [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: The time from study entry until death from any cause, assessed up to 1 year ] [ Designated as safety issue: No ]Overall survival will be calculated using the Kaplan-Meier method, and confidence limits for survival estimates will be calculated using the Greenwood formula.
| Enrollment: | 34 |
| Study Start Date: | May 2009 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients will receive AZD2171 by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies.
|
Drug: cediranib maleate
Given orally
Other Names:
Other: laboratory biomarker analysis
Procedure: computed tomography
Other Name: tomography, computed
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Other Name: DCE-MRI
Other: pharmacological study
Other Name: pharmacological studies
|
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. Determine the toxicity of this drug in these patients. II. Determine, preliminarily, the efficacy of this drug, in terms of response rate, duration of response, and overall survival, in these patients.
III. Determine the blood flow changes and vascular permeability of the tumor in patients treated with this drug.
IV. 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Criteria:
- 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
- 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427973
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Andrew Zhu | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00427973 History of Changes |
| Other Study ID Numbers: | NCI-2009-00130, DFCI IRB 05-311, N02CO12400, CDR0000526405 |
| Study First Received: | January 25, 2007 |
| Last Updated: | March 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Liver Neoplasms Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Liver Diseases Adenocarcinoma Maleic acid Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013