临床试验/NCT00095667

NCT00095667已完成2 期

A Phase 2 Study of GW572016 in Hormone Naive Recurrent or Metastatic Hormone Sensitive Prostate Cancer

National Cancer Institute (NCI)1 个研究点分布在 1 个国家目标入组 41 人开始时间: 2004年11月最近更新: 2013年5月8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: 41
试验地点: 1
主要终点: PSA response rate defined as at least a 50% fall in PSA from baseline confirmed by a second PSA 4 weeks later

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

Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Phase II trial to study the effectiveness of lapatinib in treating patients who have recurrent or metastatic prostate cancer.

详细描述

PRIMARY OBJECTIVES:

I. To determine the antitumor activity of GW572016 in hormone naïve, recurrent and/or metastatic hormone sensitive prostate cancer using PSA response rate.

SECONDARY OBJECTIVES:

I. To estimate objective tumor response in patients with measurable disease. II. To determine the duration of PSA response, rate and duration of stable disease, progression-free, median and overall survival rates of GW572016 in recurrent and/or metastatic prostate cancer.

III. To document the safety and tolerability of GW572016 in these patient populations.

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: Male
接受健康志愿者: 否

入选标准

•Patients must have histologically or cytologically confirmed prostate cancer that is recurrent after local therapy, and/or metastatic carcinoma confirmed to be of prostate origin
•Patients must have recurrent and/or metastatic disease that is progressive and not amenable to surgery or curative radiotherapy; progressive disease is defined as:
•Three consecutive rising PSAs, at least 4 weeks apart with an absolute increase of at least 0.5
•PSA doubling time of less than one year
•PSA > 2.0
•For recurrent disease following local therapy (surgery/radiation), prior neoadjuvant or adjuvant hormones are allowed if completed more than a year prior to study entry; for metastatic disease, no prior medical therapy (hormonal, corticosteroid, chemotherapy) is allowed
•Life expectancy of greater than 12 weeks
•ECOG performance status 0,1, or 2
•Leukocytes >= 3,000/uL
•Absolute neutrophil count >= 1,500/uL
•Platelets >= 100,000/uL
•Total bilirubin within normal institutional limits
•AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal
•Creatinine within normal institutional limits or creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
•Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan; note that baseline and on treatment scans should be performed using the same modality and preferably at the same institution
•Must be willing and able to undergo tumor biopsy once before (if no previous specimen available) and once during investigational therapy if there are lesions accessible for biopsy for correlative studies; in cases where there is a medical contraindication to tumor biopsy, exception may be granted only upon discussion with the principal investigator
•Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of GW572016 will be determined following review of their use by the principal investigator
•Patients requiring oral anticoagulants (coumadin, warfarin) are eligible provided there is increased vigilance with respect to monitoring INR
•Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
•Ability to understand and the willingness to sign a written informed consent document
•Able to swallow and retain oral medication

排除标准

•Prior treatment:
•Patients who have had prior chemotherapy for prostate cancer
•Patients who have been on androgen ablative therapies within the last year
•Patients receiving radiotherapy to the prostate less than 6 weeks prior to study entry
•Patients who have had prior treatment with EGFR targeting therapies
•Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier
•Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy
•Patients with a history of other active malignancy in the past 5 years (with the exception of adequately treated non-melanomatous skin cancers) are excluded
•History of allergic reactions attributed to compounds of similar chemical or biological composition to GW572016
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
•Patients with cardiac ejection fraction, not within the institutional range of normal as measured by echocardiogram or MUGA scan at baseline
•Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)
•Concomitant requirement for medication classified as CYP3A4 inducer or inhibitor

研究组 & 干预措施

Treatment (lapatinib ditosylate)

Experimental

Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

干预措施: lapatinib ditosylate (Drug)

Treatment (lapatinib ditosylate)

Experimental

Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

干预措施: laboratory biomarker analysis (Other)

结局指标

主要结局

PSA response rate defined as at least a 50% fall in PSA from baseline confirmed by a second PSA 4 weeks later

时间窗: Up to 3 years

次要结局

Objective tumor response(Up to 3 years)
Duration of PSA response(Up to 3 years)
Rate and duration of stable disease(From the start of the treatment until the criteria for progression are met, assessed up to 3 years)
Progression-free survival(From start of treatment to time criteria are met for disease progression, assessed up to 3 years)
Overall survival(Up to 3 years)
Safety and tolerability assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0(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)

Loading locations...

相似试验

已完成

2 期

Lapatinib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal CancerPrimary Peritoneal Cavity CancerRecurrent Ovarian Epithelial Cancer

NCT00113373National Cancer Institute (NCI)28

已完成

2 期

NCT00098631National Cancer Institute (NCI)88

已完成

2 期

Lapatinib in Treating Brain Metastases in Patients With Stage IV Breast Cancer and Brain MetastasesCentral Nervous System MetastasesHER2-positive Breast CancerRecurrent Breast CancerStage IV Breast CancerTumors Metastatic to BrainMale Breast Cancer

NCT00098605National Cancer Institute (NCI)37

已完成

2 期

Lapatinib in Treating Patients With Prostate Cancer That Did Not Respond to Hormone TherapyProstate Cancer

NCT00246753UNC Lineberger Comprehensive Cancer Center29

已完成

1 期

Lapatinib in Treating Patients With Recurrent Glioblastoma MultiformeBrain and Central Nervous System Tumors

NCT00099060National Cancer Institute (NCI)24