A Phase II Study of Satraplatin and Prednisone in Metastatic Androgen Independent Prostate Cancer (AIPC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Progression Free Survival.
研究概览
简要总结
Background:
Satraplatin is an experimental drug that may be of benefit to patients with prostate cancer.
Prednisone is approved for treating prostate cancer.
The gene excision repair cross-complementing rodent repair deficiency complementation group 1 (ERCC1) helps repair cell damage caused by satraplatin. It is possible that patients who have a variant of this gene will not benefit from treatment with satraplatin because the drug will not be able to damage the cancer cells effectively.
Objectives:
To determine if satraplatin may help treat prostate cancer in patients with certain variants of the ERCC1 gene.
Eligibility:
Patients with advanced androgen-independent prostate cancer whose disease has not responded to hormonal therapy or at least one type of chemotherapy and whose x-rays, scans or other tests have shown their cancer to be spreading.
Design:
Participants have a blood test to determine if they have a variant of the ERCC1 gene.
Participants take satraplatin by mouth every day for 5 consecutive days out of every 35 days and prednisone by mouth every day. These 35-day treatment cycles may continue for 6 months or longer, depending on the benefits and side effects of the treatment.
During the treatment period, patients undergo the following tests and procedures:
- Blood tests on days 1 of the treatment cycle.
- Weekly blood draws for the first 3 treatment cycles.
- Imaging studies (e.g., bone scans, computed tomography (CT) scans) every two cycles to determine the response to treatment.
- Surgical or medical suppression of testosterone in patients whose cancer cells continue to grow due to exposure to the hormone....
详细描述
Background:
- Satraplatin is an oral, third-generation platinum analog that has recently been shown to increase prostatic specific antigen (PSA) decline rates and progression-free survival in hormone-resistant prostate cancer.
- Satraplatin acts by binding to deoxyribonucleic acid (DNA) forming intra- and interstrand cross links (DNA adducts), resulting in cell-cycle arrest in G2 phase and eventual apoptosis. One of the mechanisms that bring about resistance to platinum-based chemotherapy is removal of the platinum-DNA adducts by DNA repair pathways, called nucleotide excision repair (NER) and base excision repair (BER) pathways.
- Polymorphisms in the DNA repair genes causing impaired NER and BER capability has recently been shown in some cancers, including head and neck squamous cell carcinoma, non-small cell lung carcinoma, and ovarian carcinoma to predict better treatment outcome and response to platinum treatment.
Objectives:
- Primary objective of this single arm study is to determine if the presence of ERCC1 variant gene polymorphism which is involved with DNA damage repair may be associated with an impact on the progression-free survival of patients with metastatic prostate cancer.
- Secondary objectives of this study includes demonstration of biologic effect by the drug satraplatin in the patient and in the tumor whenever possible, by obtaining tissue biopsy and white blood cell collections, to determine correlation of biologic or clinical effects with PSA progression, evaluate correlations between genotype expression, repair pathways and clinical events, and obtain laboratory correlates which will include pharmacogenetic analysis of prostate cancer patients with genotyping using Polymerase chain reaction (PCR) followed by either restriction fragment length polymorphism or direct sequencing to genotype single nucleotide polymorphisms of ERCC1, x-ray repair cross-complementing protein 1 (XRCC1), and poly (ADP-ribose) polymerase 1 (PARP1).
Eligibility:
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Satraplatin
satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
干预措施: Satraplatin (Drug)
Satraplatin
satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
干预措施: prednisone (Drug)
结局指标
主要结局
Progression Free Survival.
时间窗: 15 months
Time between the start of therapy and progression. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive Disease is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
次要结局
- Number of Participants With Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0)(Date treatment consent signed to date off study, approximately 57 months.)
- Median Overall Survival (OS)(time between the first day of treatment to the day of death, approximately 15.7 months)
研究者
William Dahut Jr., M.D.
Principal investigator
National Institutes of Health Clinical Center (CC)