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Chemoembolization in Treating Patients With Primary Liver Cancer or Metastases to the Liver

Phase 2
Completed
Conditions
Liver Cancer
Metastatic Cancer
Interventions
Registration Number
NCT00003907
Lead Sponsor
Eastern Cooperative Oncology Group
Brief Summary

RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor.

PURPOSE: Phase II trial to study the effectiveness of chemoembolization in treating patients who have primary liver cancer or metastases to the liver that cannot be surgically removed.

Detailed Description

OBJECTIVES:

* Evaluate time to progression of disease in patients with unresectable hepatocellular carcinoma or neuroendocrine hepatic metastases undergoing chemoembolization.

* Evaluate tumor response achievable with chemoembolization in this patient population.

* Evaluate the toxicities of this treatment in these patients.

* Evaluate survival of these patients following this treatment.

* Evaluate extrahepatic patterns of failure following chemoembolization, to determine whether intrahepatic progression may be forestalled and survival affected in these patients.

* Validate a consistent method of performing chemoembolization in a multicenter setting.

OUTLINE: Patients are stratified according to disease (hepatocellular carcinoma vs neuroendocrine hepatic metastases).

Patients undergo placement of a visceral arterial catheter. Patients receive doxorubicin, mitomycin, and cisplatin as a chemoemulsion via the arterial catheter into 1 hepatic lobe only. Immediately following delivery of the chemoemulsion, particulate embolization is performed. The opposite lobe, if involved, is treated within 3-5 weeks of treatment of the initial lobe.

In the absence of unacceptable toxicity, each involved lobe is treated separately a second time, in the same sequence, beginning 8 weeks after the last lobular chemoembolization. After completion of all protocol therapy, retreatment on study of either lobe is allowed for regrowth, recurrence, or new disease, provided at least 3 months have elapsed since the initial treatment of that lobe.

Patients are followed for 5 years.

PROJECTED ACCRUAL: A total of 19-42 patients will be accrued for this study within 1 year.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
Inclusion Criteria
  • Biopsy-proven intrahepatic hepatocellular carcinoma or neuroendocrine tumor.
  • Unresectable.
  • Bidimensionally measurable disease by Computed Tomography (CT), Magnetic resonance imaging (MRI), or UltraSound Scanning (US) within 6 weeks of registration.
  • Evidence of patent portal vasculature by Doppler US, MRI, or angiography.
  • Serum total bilirubin < 2.0 mg/dl and serum creatinine < 2.0 mg/dl within 4 weeks of registration.
  • Absolute neutrophil count (ANC) > 2000/µl and platelets > 50,000/µl within 4 weeks of registration.
  • Expected survival of at least 3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Age >= 18 years.
Exclusion Criteria
  • Evidence of extrahepatic disease that is likely to be life-threatening within 3 months, such as brain or symptomatic lung metastases.
  • Previous intra-arterial or intra-hepatic chemotherapy or prior systemic chemotherapy within 4 weeks.
  • Concurrent malignancy.
  • Pregnant or breast-feeding women.
  • History of life-threatening contrast allergy.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Hepatocellular carcinomacisplatinChemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
Neuroendocrine hepatic metastasesembolizationChemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
Hepatocellular carcinomaembolizationChemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
Hepatocellular carcinomadoxorubicinChemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
Neuroendocrine hepatic metastasesdoxorubicinChemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
Hepatocellular carcinomamitomycinChemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
Neuroendocrine hepatic metastasescisplatinChemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
Neuroendocrine hepatic metastasesmitomycinChemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
Primary Outcome Measures
NameTimeMethod
Time to ProgressionAssessed every 3 months for 2 years, then every 6 months for 3 year.

Time to progression was defined as time from embolization to documented disease progression. Patients without documented progression were censored at the time of the last documented disease evaluation or of the last treatment ended, whichever was more recent.Disease progression was defined as significant increase in size of lesions or appearance of new metastatic lesions. Specifically, 1) \>=25% increase in the area of any malignant lesions greater than 2 cm² or in the sum of the products of the individual lesions in a given organ site; 2)\>=50% increase in the size of the product of diameters if only one lesion is available for measurement and was less than or equal to 2 cm² in size at the initiation of therapy; 3)\>=25% increase in the sum of the liver measurements below the costal margins and xyphoid; 4)Appearance of new malignant lesions

Secondary Outcome Measures
NameTimeMethod
Tumor ResponseAssessed every 6 weeks

Clinical complete response was defined as complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response was defined as \>= 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease. Tumor response was defined as complete response + partial response.

Overall SurvivalAssessed every 3 months for 2 years, then every 6 months for 3 year.

Overall survival was defined as time from registration to death from any causes.

Trial Locations

Locations (37)

Front Range Cancer Specialists

🇺🇸

Fort Collins, Colorado, United States

Baptist Cancer Institute - Jacksonville

🇺🇸

Jacksonville, Florida, United States

Winship Cancer Institute of Emory University

🇺🇸

Atlanta, Georgia, United States

Veterans Affairs Medical Center - Atlanta (Decatur)

🇺🇸

Decatur, Georgia, United States

Rush-Copley Cancer Care Center

🇺🇸

Aurora, Illinois, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

🇺🇸

Chicago, Illinois, United States

Hematology and Oncology Associates

🇺🇸

Chicago, Illinois, United States

Veterans Affairs Medical Center - Lakeside Chicago

🇺🇸

Chicago, Illinois, United States

Mercy Hospital and Medical Center

🇺🇸

Chicago, Illinois, United States

Swedish Covenant Hospital

🇺🇸

Chicago, Illinois, United States

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Front Range Cancer Specialists
🇺🇸Fort Collins, Colorado, United States

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