Doxorubicin and Bortezomib in Treating Patients With Liver Cancer

Inclusion Criteria

• Patients must have microscopically confirmed hepatocellular carcinoma not amenable to curative resection; if patients have an isolated lesion in one lobe of the liver, a liver surgeon should determine resectability; central review is not required
• Patients must have measurable disease as determined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria, amenable to biopsy; patients are not mandated to allow biopsy, even though it is an important aspect of this clinical trial
• Patients with history of malignancy treated within the past 5 years are not eligible; history of carcinoma-in-situ of cervix, squamous cell cancer of skin, basal cell cancer of skin, previously treated are allowed; others are excluded as recurrence of disease may confuse response rate and/or survival endpoints
• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Patients must not have had prior systemic chemotherapy for HCC; patients on antineoplastics for non-malignant diseases, such as methotrexate for rheumatoid arthritis, are allowed, providing patients have been off these agents for at least 4 weeks and all related toxicities have resolved to baseline
• Patients may have had prior embolization without chemotherapy; patients who have had chemoembolization are not eligible; patients may have had radiofrequency (RF) ablation, cryosurgery or ethanol injection; patients must have documented progression with the involved lesion or at least one previously untreated lesion amenable to biopsy
• Platelet count must be >= 100, 000/mm^3 in absence of splenomegaly; platelet count must be >= 75,000/mm^3 with splenomegaly
• Absolute neutrophil count (ANC) must be >= 1,500/mm^3 in absence of splenomegaly; ANC must be = 1.5 or Partial thromboplastin time (PTT) > 1.5 x institutional ULN (required due to biopsy portion of study); use of vitamin K or fresh frozen plasma to correct values just prior to biopsy or enrollment is not allowed are not eligible

Exclusion criteria

• Patients have baseline peripheral neuropathy > grade 1
• Patients with history of untreated malignancy other than HCC
• Patients have had prior use of octreotide or tamoxifen as therapy for HCC
• Patients with known allergy to boron, mannitol or bortezomib
• Women are pregnant or breast-feeding (due to the uncertain effects of bortezomib in the developing fetus and young infants)
• Patients have an underlying medical condition that precludes safe participation in this clinical trial
• Patients have psychiatric illness or continued substance abuse that may impair the ability to provide informed consent or prevent safe administration of bortezomib
• Patients with ejection fraction (EF) < 50% measured by Echocardiography (ECHO) or Multiple gated acquisition (MUGA)
• Patients on verapamil who cannot be switched to an alternative medication (due to the interaction with doxorubicin)