A Phase II Study to Evaluate the Effects of Docetaxel Plus Lycopene in Castration Resistant, Chemotherapy-Naïve Prostate Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Proporation of Subjects Achieving Partial Response, Stable Disease or Progressive Disease Based on PSA Response Rates
研究概览
简要总结
This phase II trial evaluated the impact of giving docetaxel together with lycopene supplements in treating patients with hormone-resistant prostate cancer not previously treated with chemotherapy. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoprevention is the use of certain drugs, such as lycopene, to keep cancer from forming. Giving docetaxel together with lycopene may be an effective treatment for prostate cancer.
详细描述
PRIMARY OBJECTIVES:
I. To define the prostate-specific antigen (PSA) response rate according to the criteria of Bubley, et al. (>50% reduction from baseline) in subjects treated with a combination of docetaxel and lycopene.
SECONDARY OBJECTIVES:
I.To determine the objective response rate (ORR) according to modified RECIST criteria in patients with measurable disease, following treatment with docetaxel and lycopene.
II. To define the time to PSA progression, according to the response criteria of Scher, et al., in subjects treated with docetaxel and lycopene.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient must have a histological diagnosis of adenocarcinoma of the prostate and 2 rising pre-study PSA values >= 1 ng/ml at least 1 week apart within 28 days prior to enrollment
- •Patients must be unresponsive to androgen-deprivation therapy (ADT), as indicated by a rising PSA level above the ADT nadir
- •Patient must not have received chemotherapy, biologic therapy, or any other investigational drug for any reason within 28 days prior to start of therapy, and must have recovered from toxicities of prior therapy to grade 1 or less
- •Patients must have been surgically or medically castrated; if the patient is being treated with medical castration, he must be willing to continue this treatment for the duration of the study; ADT should not be initiated, terminated, or dose-adjusted during the study
- •Prior external beam radiation therapy (to less than 30% of the bone marrow only) is allowed; at least 28 days must have elapsed since the completion of radiation therapy and the patient must have recovered from side effects; prior treatment with samarium-153 or strontium-86 is allowed if at least eight weeks have elapsed since dosing, and all toxicities have resolved to grade 1; soft tissue disease which has been radiated in the prior 2 months is not assessable as measurable disease
- •Patients may have received prior surgery; however, at least 21 days must have elapsed since completion of surgery and the patient must have recovered from all side effects
- •Normal serum bilirubin and serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvate transaminase (SGPT) =< 1.5 x the institutional upper limit of normal obtained within 14 days prior to start of therapy; liver function tests should be evaluated prior to each treatment
- •Serum creatinine =< 1.5 x the institutional upper limit of normal obtained within 14 days prior to start of therapy
- •Men of child bearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
- •Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Absolute neutrophil count >= 1,500/microliter (mcL)
- •Hemoglobin of >= 8.0gm/dL
- •White blood cell count > 2,500/mcL
- •Platelets >= 100,000/mcL
- •Patients with lower values may participate if, in the opinion of the investigator, the cytopenias are the result of bone marrow involvement with active prostate cancer
- •Patients must be able to take oral medications
- •All patients must be informed and must sign and give written informed consent in accordance with institutional and federal guidelines; patients who are unable to comply with study and/or follow-up procedures are ineligible
排除标准
- •Uncontrolled brain or spinal cord metastases
- •History of congestive heart failure or myocardial infarction within the previous six months
- •History of allergy or hypersensitivity to any component of the study drugs
- •Evidence or history of a bleeding diathesis or coagulopathy, including therapy-induced coagulopathy
- •Presence of chronic diarrhea (> grade 1 by Common Toxicity Criteria (CTC)), short bowel syndrome, pancreatic insufficiency, or malabsorption
- •Presence of any severe or uncontrolled concurrent medical condition which, in the opinion of the investigator, would increase the risk of serious toxicity from the study drugs
- •Concurrent use of any vitamin, herb, or mineral supplements for at least 14 days prior to start of therapy
研究组 & 干预措施
Treatment (docetaxel and lycopene)
Patients receive docetaxel IV over 1 hour on day 2 and lycopene PO once daily on days 1-21. Treatment repeats every 21days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Docetaxel (Drug)
Treatment (docetaxel and lycopene)
Patients receive docetaxel IV over 1 hour on day 2 and lycopene PO once daily on days 1-21. Treatment repeats every 21days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Lycopene (Dietary Supplement)
结局指标
主要结局
Proporation of Subjects Achieving Partial Response, Stable Disease or Progressive Disease Based on PSA Response Rates
时间窗: Up to week 12 of therapy
To define the prostate-specific antigen (PSA) response rate according to the criteria of Bubley, et al. in subjects treated with a combination of docetaxel and lycopene. Per criteria of Bubley, et al., PSA response rate is defined the number of subjects who achieve a \>50% decline in PSA from baseline.
次要结局
- Time to PSA Progression(Up to 4 years)
- Objective Response Rate as Assessed by RECIST Criteria in Either Visceral or Lymph Node Metastases(Up to 4 years)
- Toxicity of Combined Docetaxel + Lycopene Therapy(Up to 4 years)
研究者
John P. Fruehauf
Professor of Clinical Medicine
University of California, Irvine