Hepatic Arterial Chemoembolization With Cisplatin or Internal Radiation Therapy in Treating Patients With Advanced Liver Cancer That Cannot Be Removed By Surgery

NCT00109954 | Completed Phase 3 DMC

• 3 other identifiers: PCI-04128CDR0000425333PCI-IRB-0501021
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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, chemotherapy is given through the artery (hepatic artery) that brings blood to the tumor. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether hepatic arterial chemoembolization with cisplatin is more effective than internal radiation therapy in treating liver cancer. PURPOSE: This randomized phase III trial is studying hepatic arterial chemoembolization with cisplatin to see how well it works compared to internal radiation therapy in treating patients with advanced liver cancer that cannot be removed by surgery.

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinoma; advanced adult primary liver cancer; localized unresectable adult primary liver cancer; recurrent adult primary liver cancer

Outcome Measures

Primary Outcomes (3)

• Progression-free survival as assessed by tumor progression in the treated lobe of the liver

• Health-related quality of life at baseline and every 3 months

• Toxicity as measured by NCI CTCAE version 3.0

Interventions

cisplatin DRUG

brachytherapy RADIATION

yttrium Y 90 glass microspheres RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

Cisplatin; Brachytherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Radiotherapy; Therapeutics

Study Officials

• Brian I. Carr, MD

  University of Pittsburgh

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 3, 2005
• First Posted: May 4, 2005
• Study Start: February 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: January 18, 2016

Record last verified: 2015-03

Locations

US (1)