临床试验/NCT00103194

NCT00103194已完成2 期

Phase II Trial of GW572016 in Patients With Recurrent Prostate Cancer as Evident by a Rising PSA

National Cancer Institute (NCI)1 个研究点分布在 1 个国家目标入组 49 人开始时间: 2005年9月最近更新: 2014年9月30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: 49
试验地点: 1
主要终点: Number of Patients With PSA Response, Defined as a 50% or Greater Decline in the Serum PSA Level

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 studies how well lapatinib ditosylate works in treating patients with a rising prostate-specific antigen (PSA), a protein made by the prostate gland, indicating that prostate cancer has come back after previous treatment. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may delay or prevent the progression of prostate cancer.

详细描述

PRIMARY OBJECTIVES:

I. To evaluate the percentage of patients with hormone sensitive prostate cancer who experience > 50% decline in serum PSA during treatment with GW572016 (lapatinib ditosylate).

SECONDARY OBJECTIVES:

I. To evaluate the duration of PSA decline. II. To characterize the change in PSA slope with GW572016. III. To characterize the safety and tolerability of GW572016 in this patient population.

IV. To estimate the time to progression (TTP) and progression-free survival at 2 years (from start of therapy).

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

•Histologically confirmed diagnosis of prostate cancer
•Previous treatment with definitive surgery or radiation therapy
•Prior salvage therapy (surgery, radiation, or other local ablative procedures) is allowed if the intent was for cure
•No evidence of metastatic disease on physical exam, computed tomography (CT) (magnetic resonance imaging [MRI]), and bone scan
•Prior neoadjuvant/adjuvant hormonal or chemotherapy and investigational agents are allowed if it was last used >= 1 year prior to enrollment (no prior vaccine/immunotherapy for prostate cancer will be allowed)
•No therapy modulating testosterone levels (such as luteinizing-hormone releasing-hormone agonists/antagonists and antiandrogens) is permitted within 1 year prior to enrollment; agents such as 5alpha-reductase inhibitors, ketoconazole, megestrol acetate, systemic steroids, or herbal supplements are not permitted at any time during the period that the PSA values are being collected
•Hormone-sensitive prostate cancer as evident by a serum total testosterone level > 150 ng/dL within 4 weeks prior to registration
•All patients must have evidence of biochemical progression as determined by a reference PSA value followed by 2 rising PSA values, each higher than the previous value, obtained at least 6 weeks apart; all of these PSA values must be obtained at the same reference lab, and all must be done within 6 months prior to enrollment
•The most recent of the PSA values must be greater than 0.4 ng/ml (after prostatectomy) or greater than 1.5 ng/ml (after radiation therapy) at time of enrollment; this measurement must be obtained within 6 months prior to enrollment
•PSA doubling time (PSADT) must be =< 365 days
•Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
•Leukocytes >= 3000/mm^3
•Granulocytes >= 1500/mm^3
•Platelet count >= 100,000/mm^3
•Serum creatinine within normal institutional limits or creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
•Serum total bilirubin within normal institutional limits
•Serum alkaline phosphatase within normal institutional limits
•Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamic pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x institutional upper limit of normal
•Cardiac ejection fraction within the institutional range of normal, as measured by echocardiogram or multi gated acquisition scan (MUGA) scan within 4 weeks prior to registration; note that baseline and on-treatment scans should be performed using the same modality and preferably at the same institution
•No unstable arrhythmias on electrocardiogram (ECG) are allowed (rate controlled, asymptomatic atrial fibrillation is allowed)
•No concomitant use of any medication classified as cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inducer or inhibitor; for patients previously treated with one of these prohibited medications, the prohibited agent needs to be discontinued, either 7 days, 14 days, or 6 months prior to the administration of the first dose of study medication
•Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
•Normal prothrombin time (PT)/international normalized ratio (INR) within 4 weeks prior to registration
•Able to swallow and retain oral medication
•Patients with gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis) will not be eligible
•Sexually active males are strongly advised to use an accepted and effective method of contraception
•Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy
•No history of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016
•No 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
•No other malignancies permitted within the past 5 years with the exception of non-melanoma skin cancer treated with curative intent

排除标准

未提供

研究组 & 干预措施

Treatment (lapatinib ditosylate)

Experimental

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

干预措施: lapatinib ditosylate (Drug)

Treatment (lapatinib ditosylate)

Experimental

Patients receive lapatinib ditosylate PO daily on days 1-28. Courses repeat every 28 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

Number of Patients With PSA Response, Defined as a 50% or Greater Decline in the Serum PSA Level

时间窗: Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years

PSA response is defined as either complete response (CR) or partial response (PR) observed at any time during the entire measurement time period. CR: In patients treated with prior radical prostatectomy, a PSA \< 0.2 ng/mL confirmed by a repeat PSA at least one month apart was considered a complete biochemical response. In patients treated with radiation therapy only, a PSA \< 1 ng/mL on three separate occasions taken at least one month apart was considered a complete biochemical response. PR: A reduction in PSA by \> 50% from baseline, confirmed by repeat PSA 1 month later.

次要结局

The Change in PSA Slope With GW572016 (Lapatinib)(Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually, for 5 years)
Progression-free Survival Rate at 2 Years(Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years)
Relationship Between Progression-free Survival and EGFR Expression Levels(Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 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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