Chemoembolization in Treating Patients With Primary Liver Cancer or Metastases to the Liver
Condition: Liver Cancer; Metastatic Cancer
MeSH terms: Neoplasm Metastasis; Liver Neoplasms
Intervention: cisplatin; doxorubicin; mitomycin; embolization
Intervention description: Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).; Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).; Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray).; Immediately following delivery of the chemoemulsion, particulate embolization is performed. The particulate embolic material is prepared on a separate table or tray, using absorbable gelatin sponge (Gelfoam, Upjohn, Kalamazoo, MI), in either powder or pledget form. Approximately 1 g of this temporary occlusive agent is dissolved in 20-30 cc of full-strength contrast with 2.4 cc of absolute alcohol.
Intervention MeSH terms: Cisplatin; Doxorubicin; Liposomal doxorubicin; Mitomycins; Mitomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: localized unresectable adult primary liver cancer; advanced adult primary liver cancer; recurrent adult primary liver cancer; adult primary hepatocellular carcinoma; liver metastases

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.
    

Eligibility 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.