Bortezomib in Treating Patients With Hepatocellular Carcinoma (Liver Cancer)

NCT00077441 | Completed Phase 2

• 3 other identifiers: NCI-2012-02806MC0255N01CM62205
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well bortezomib works in treating patients with hepatocellular carcinoma (liver cancer) that cannot be removed with surgery. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

Conditions

Adult Primary Hepatocellular Carcinoma; Advanced Adult Primary Liver Cancer; Localized Unresectable Adult Primary Liver Cancer; Recurrent Adult Primary Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of confirmed tumor responses, defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 6 weeks apart

  Ninety-five percent confidence intervals for the true success proportion will be calculated.

  Up to 36 weeks (12 courses)

Secondary Outcomes (4)

• Survival time

  Time from registration to death due to any cause, assessed up to 3 years

• Time to disease progression

  Time from registration to documentation of disease progression, assessed up to 3 years

• Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented

  Up to 3 years

• Time to treatment failure

  Time from the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 3 years

Study Arms (1)

Treatment (bortezomib)

EXPERIMENTAL

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: bortezomib; Other: laboratory biomarker analysis

Interventions

bortezomib DRUG

Given IV

Also known as: LDP 341, MLN341, VELCADE

Treatment (bortezomib)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (bortezomib)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed hepatocellular carcinoma (HCC) that is not amenable to surgical resection
• Must have measurable disease; NOTE: For patients having only lesions measuring \> 1 cm to =\< 2 cm must use spiral CT imaging for all tumor assessments
• Absolute neutrophil count (ANC) \>= 1500/mm\^3
• PLT \>= 75,000/mm\^3
• Total bilirubin =\< 3 x upper normal limit (UNL)
• Serum AST =\< 5 x UNL
• Serum ALT =\< 5 x UNL
• Serum creatinine =\< 2 mg/dL
• Serum albumin \>= 2.5 g/dL
• PT/ INR =\< 1.5 (EXCEPTION - Patients with full-dose anticoagulants are eligible provided the patient has been on a stable dose, \>= 2 weeks, of warfarin or low molecular weight heparin and has an PT/INR range 2-3)
• Child-Pugh classification of A or B
• Patients may not have received prior systemic chemotherapy BUT may have received prior chemoembolization, cryotherapy, radiofrequency ablation, ethanol injection, or photodynamic therapy, provided the following criteria are met:
• \> 6 weeks has elapsed since that therapy
• Indicator lesion(s) is/are outside the area of prior treatment or, if the only indicator lesion is inside the prior treatment area, there must be clear evidence of disease progression associated with that lesion
• Edges of the indicator lesion are clearly distinct on CT scanning

You may not qualify if:

• Any of the following:
• Prior systemic anticancer therapy. Note: Chemoembolization is allowed and for trial purposes is not considered a systemic chemotherapy; however, \>= 6 weeks must have elapsed between chemoembolization and enrollment on this study
• Prior PS-341 therapy
• Immunotherapy =\< 4 weeks have elapsed prior to study entry
• Biologic therapy =\< 4 weeks have elapsed prior to study entry
• Radiation therapy =\< 4 weeks have elapsed prior to study entry
• Cryotherapy =\< 6 weeks have elapsed since prior to study entry
• Radiofrequency ablation =\< 6 weeks have elapsed since prior to study entry
• Ethanol injection =\< 6 weeks have elapsed since prior to study entry
• Photodynamic therapy =\< 6 weeks have elapsed since prior to study entry
• Major surgery, or significant traumatic injury =\< 3 weeks prior to study entry
• Other concurrent chemotherapy, immunotherapy, radiotherapy, or any other therapy or supportive care considered investigational
• Presence of \> grade 1 sensory peripheral neuropathy of any etiology OR grade 1 with neuropathic pain of any etiology
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to PS-341
• History of other malignancy =\< 3 years prior to study entry, except for adequately treated basal cell or squamous cell skin cancer

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• George Kim

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2004
• First Posted: February 12, 2004
• Study Start: April 1, 2005
• Primary Completion: June 1, 2006
• Last Updated: June 4, 2013

Record last verified: 2013-06

Locations

US (1)