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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Doxorubicin; Liposomal doxorubicin; Mitomycin; Mitomycins

Criteria

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.