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A Phase II Study of AZD2171 in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer

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Trial Information

A Phase II Study of AZD2171 in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival after 6 months of treatment

Outcome 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.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Steven Alberts

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01822

NCT ID:

NCT00238394

Start Date:

December 2005

Completion Date:

Related Keywords:

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

Name

Location

North Central Cancer Treatment GroupRochester, Minnesota  55905