Status:
COMPLETED
Hepatic Arterial Chemoembolization With Cisplatin or Internal Radiation Therapy in Treating Patients With Advanced Liver Cancer That Cannot Be Removed By Surgery
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Liver Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. In this case, chemoth...
Detailed Description
OBJECTIVES: Primary * Compare time to disease progression in patients with unresectable advanced hepatocellular carcinoma treated with cisplatin-based trans-arterial chemoembolization vs hepatic int...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following:
- Histologically or cytologically confirmed hepatocellular carcinoma (HCC)
- Confined to the liver
- Vascular liver mass in the presence of cirrhosis
- Alpha-fetoprotein level \> 500 ng/mL
- Measurable disease
- At least 1 unidimensionally measurable lesion \> 20 mm by spiral CT scan
- Unresectable disease, due to tumor size or extent or presence of cirrhosis
- No metastatic disease, including brain metastases
- Locoregional lymph node metastases allowed
- No evidence of potential delivery of \> 16.5 miCi (30 Gy absorbed dose) of radiotherapy to the lungs either during the first administration of yttrium Y 90 glass microspheres (TheraSphere®) or on cumulative delivery of radiation to the lungs over multiple treatments\*
- No evidence of detectable technetium Tc 99m macroaggregated albumin (Tc-99m MAA) flow to the stomach or duodenum after application of established angiographic techniques to stop the flow\* NOTE: \*For patients randomized to the TheraSphere® arm only
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- More than 12 weeks
- Hematopoietic
- WBC \> 2,500/mm\^3
- Absolute neutrophil count \> 1,500/mm\^3
- Platelet count \> 60,000/mm\^3
- No bleeding diathesis not correctable by usual forms of therapy
- Hepatic
- See Disease Characteristics
- Bilirubin \< 2.0 mg/dL
- AST and/or ALT ≤ 5 times upper limit of normal
- Hepatitis allowed
- No portal hypertension with hepatofugal flow
- Renal
- Creatinine \< 2.5 mg/dL
- Cardiovascular
- No symptomatic congestive heart failure
- No severe peripheral vascular disease that would preclude catheterization
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double barrier or hormonal contraception during and for at least 30 days after completion of study treatment
- No ongoing or active infection
- No other uncontrolled illness
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- No more than 1 prior systemic chemotherapy for HCC
- More than 4 weeks since prior IV chemotherapy and recovered
- More than 1 year since prior hepatic arterial cisplatin
- More than 4 months since other prior hepatic arterial chemotherapy
- Endocrine therapy
- Not specified
- Radiotherapy
- No prior external hepatic radiotherapy for HCC
- Surgery
- Not specified
- Other
- No other concurrent therapy for HCC
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2005
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00109954
Start Date
February 1 2005
End Date
December 1 2005
Last Update
January 18 2016
Active Locations (1)
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1
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232