Phase II Trial of PS-341 in Patients With Hepatocellular Carcinoma
bortezomib
+ laboratory biomarker analysis
Adenocarcinoma+8
+ Carcinoma
+ Digestive System Diseases
Treatment Study
Summary
Study start date: April 1, 2005
Actual date on which the first participant was enrolled.PRIMARY OBJECTIVES: I. Proportion of confirmed tumor responses. SECONDARY OBJECTIVES: I. To evaluate the confirmed and objective response rate. II. To assess patient outcome as estimated by duration of response, time to disease progression, and survival. III. To evaluate the adverse event rates associated with PS-341 in this population. IV. To explore the relationships between laboratory correlates (eg. IHC) and patient outcome (eg p53 and disease progression). V. To evaluate alterations in laboratory correlates from pre-treatment measurements (ie, pre and post treatment). The following immunohistochemistry (IHC) assays will be performed: IHC of p53, IHC of p21, IHC of p27, IHC of NFkB, IHC of Ki67. OUTLINE: This is a multicenter study. 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. Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from study entry.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.55 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * 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 * ECOG performance status (PS) 0, 1, or 2 * Estimated life expectancy \>= 24 weeks * Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide written informed consent Exclusion Criteria: * 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 * Any of the following as this regimen may be harmful to a developing fetus or nursing child: * Pregnant women * Breastfeeding women * Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, or abstinence, etc.) * Known CNS metastases * Uncontrolled intercurrent illness including, but not limited to: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris, cardiac arrhythmia * Psychiatric illness that would limit compliance with study requirements * HIV-positive patients receiving combination anti-retroviral therapy
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location