临床试验/NCT00077441

NCT00077441已完成2 期

Phase II Trial of PS-341 in Patients With Hepatocellular Carcinoma

National Cancer Institute (NCI)1 个研究点分布在 1 个国家目标入组 55 人开始时间: 2005年4月最近更新: 2013年6月4日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: National Cancer Institute (NCI)
入组人数: 55
试验地点: 1
主要终点: 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

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

•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

研究组 & 干预措施

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.

干预措施: bortezomib (Drug)

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.

干预措施: laboratory biomarker analysis (Other)

结局指标

主要结局

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

时间窗: Up to 36 weeks (12 courses)

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

次要结局

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)

研究者

发起方

National Cancer Institute (NCI)

申办方类型

Nih

责任方

Sponsor

研究点 (1)

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