search
Back to results

Cediranib Maleate in Treating Patients With Locally Advanced or Metastatic Liver Cancer

Primary Purpose

Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cediranib maleate
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Primary Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • North Central Cancer Treatment Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (cediranib maleate)

Arm Description

Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a CR receive 2 additional courses beyond CR. Patients experiencing disease progression within 5 years after completion of study treatment may receive additional courses of study treatment.

Outcomes

Primary Outcome Measures

Survival after 6 months of treatment
Will be estimated by the proportion of patients surviving more than 6 months. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Time to disease progression
Will be estimated using the method of Kaplan-Meier.

Secondary Outcome Measures

Confirmed tumor response is defined to be a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart
Laboratory measures
Descriptive statistics will be computed for the laboratory measures, including frequency and Cox proportional hazards modeling.

Full Information

First Posted
October 12, 2005
Last Updated
June 4, 2013
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00238394
Brief Title
Cediranib Maleate in Treating Patients With Locally Advanced or Metastatic Liver Cancer
Official Title
A Phase II Study of AZD2171 in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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 AZD2171 works in treating patients with locally advanced or metastatic liver cancer.
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 and time to progression in patients treated with this drug. II. Determine the toxicity of this drug in these patients. III. Correlate biological markers with response in patients treated with this drug. 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. Patients achieving a complete response (CR) receive 2 additional courses beyond CR. Patients experiencing disease progression within 5 years after completion of study treatment may receive additional courses of study treatment. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 4 years. PROJECTED ACCRUAL: A total of 20-44 patients will be accrued for this study within 22 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (cediranib maleate)
Arm Type
Experimental
Arm Description
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a CR receive 2 additional courses beyond CR. Patients experiencing disease progression within 5 years after completion of study treatment may receive additional courses of study treatment.
Intervention Type
Drug
Intervention Name(s)
cediranib maleate
Other Intervention Name(s)
AZD2171, Recentin
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Survival after 6 months of treatment
Description
Will be estimated by the proportion of patients surviving more than 6 months. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Time Frame
6 months
Title
Time to disease progression
Description
Will be estimated using the method of Kaplan-Meier.
Time Frame
From registration to documentation of disease progression, assessed up to 5 years
Secondary Outcome Measure Information:
Title
Confirmed tumor response is defined to be a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart
Time Frame
Up to 5 years
Title
Laboratory measures
Description
Descriptive statistics will be computed for the laboratory measures, including frequency and Cox proportional hazards modeling.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Alberts
Organizational Affiliation
North Central Cancer Treatment Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Central Cancer Treatment Group
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Cediranib Maleate in Treating Patients With Locally Advanced or Metastatic Liver Cancer

We'll reach out to this number within 24 hrs