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

NCT ID: NCT00238394

Last Updated: 2013-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (cediranib maleate)

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.

Group Type: EXPERIMENTAL

cediranib maleate

Intervention Type: DRUG

Given orally

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

cediranib maleate

Given orally

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

AZD2171; Recentin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Alberts

Role: PRINCIPAL_INVESTIGATOR

North Central Cancer Treatment Group

Locations

North Central Cancer Treatment Group

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

N044J

Identifier Type: -

Identifier Source: secondary_id

CDR0000446081

Identifier Type: -

Identifier Source: secondary_id

NCCTG-N044J

Identifier Type: -

Identifier Source: secondary_id

U10CA025224

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-01822

Identifier Type: -

Identifier Source: org_study_id