Anti-inhibitor Coagulant Complex |
Autoplex T; FEIBA VH Immuno |
Clinical Trial: AZD2171 in Treating Patients With Locally Advanced or Metastatic Liver Cancer
This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) October 2005
Purpose
RATIONALE: 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.
PURPOSE: This phase II trial is studying how well AZD2171 works in treating patients with locally advanced or metastatic liver cancer.
| Condition | Intervention | Phase |
|---|---|---|
| Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Localized Unresectable Adult Primary Liver Cancer | Drug: AZD2171 Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: biological response modifier therapy Procedure: enzyme inhibitor therapy Procedure: growth factor antagonist therapy Procedure: protein tyrosine kinase inhibitor therapy | Phase II |
MedlinePlus related topics: Liver Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of AZD2171 in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma
OBJECTIVES:
Primary
- Determine the 6-month survival of patients with locally advanced or metastatic hepatocellular carcinoma treated with AZD2171.
Secondary
- Determine tumor response and time to progression in patients treated with this drug.
- Determine the toxicity of this drug in these patients.
- 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.
Eligibility
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,200/mm^3
- Platelet count ≥ 75,000/mm^3
- Hemoglobin ≥ 10.0 g/dL
Hepatic
- Bilirubin ≤ 3 times upper limit of normal (ULN)
- AST ≤ 5 times ULN
- Alkaline phosphatase ≤ 5 times ULN
Renal
- Not specified
Cardiovascular
- 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
Other
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy
- 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
Chemotherapy
- 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
Endocrine therapy
- More than 4 weeks since prior hormonal therapy
Radiotherapy
- 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 other prior radiotherapy for this cancer
- No prior radiotherapy to ≥ 25% of the bone marrow
- No concurrent radiotherapy
Surgery
- See Disease Characteristics
Other
- No concurrent combination antiretroviral therapy for HIV-positive patients
Location and Contact Information
Steven R. Alberts, MD, Study Chair, Mayo Clinic
Jamie R. Merchan, MD, Mayo Clinic
More Information
Clinical trial summary from the National Cancer Institute''''s PDQ® database
Last Updated: December 8, 2005
Record first received: October 12, 2005
ClinicalTrials.gov Identifier: NCT00238394
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10
Resources
- Anti-inhibitor Coagulant Complex (Drug Digest)
- Autoplex T (Drug Digest)

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