Phase II Trial of Carboplatin and Everolimus (RAD001) in Metastatic Castrate Resistant Prostate Cancer (CRPC) Pretreated With Docetaxel Chemotherapy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- Time to Progression (TTP)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as carboplatin and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving carboplatin together with everolimus and prednisone may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving carboplatin together with everolimus and prednisone works in treating patients with metastatic prostate cancer that progressed after docetaxel.
详细描述
OBJECTIVES:
Primary
- To evaluate the time to progression (TTP) achieved with carboplatin and everolimus in patients with castrate resistant metastatic prostate cancer that progressed after docetaxel-based chemotherapy.
Secondary
- To evaluate the safety of this regimen.
- To assess the PSA response rate in patients treated with this regimen.
- To evaluate the overall survival (OS) outcome in these patients.
- To investigate the association of TTP and PSA response rate with correlative markers, such as phospho mTOR, pAKT, and p70S6.
- To evaluate the pharmacokinetics of this regimen.
- To explore the association of TTP, OS, and circulating tumor tumor cell count.
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 120 Years（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
Carboplatin, RAD 001 & Prednisone
Carboplatin: AUC=4 by Calvert's formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle
RAD 001: 5 mg Orally daily, starting from Day 2 continuously
Prednisone 5 mg Orally twice daily, continuously
干预措施: carboplatin (Drug)
Carboplatin, RAD 001 & Prednisone
Carboplatin: AUC=4 by Calvert's formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle
RAD 001: 5 mg Orally daily, starting from Day 2 continuously
Prednisone 5 mg Orally twice daily, continuously
干预措施: RAD 001 (Drug)
Carboplatin, RAD 001 & Prednisone
Carboplatin: AUC=4 by Calvert's formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle
RAD 001: 5 mg Orally daily, starting from Day 2 continuously
Prednisone 5 mg Orally twice daily, continuously
干预措施: prednisone (Drug)
Carboplatin, RAD 001 & Prednisone
Carboplatin: AUC=4 by Calvert's formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle
RAD 001: 5 mg Orally daily, starting from Day 2 continuously
Prednisone 5 mg Orally twice daily, continuously
干预措施: laboratory biomarker analysis (Other)
Carboplatin, RAD 001 & Prednisone
Carboplatin: AUC=4 by Calvert's formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle
RAD 001: 5 mg Orally daily, starting from Day 2 continuously
Prednisone 5 mg Orally twice daily, continuously
干预措施: pharmacological study (Other)
结局指标
主要结局
Time to Progression (TTP)
时间窗: Up to 63 days while on treatment, then up 90 days thereafter. From date of registration to date of progressive disease.
Progression defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
次要结局
- PSA Response Rate(Day 1 of each cycle (every 21 days), through study completion, an average of 6 months)
- Association of PSA Response Rate With Correlative Markers (Phospho mTOR, pAKT, and p70S6)(Archival tissue will be collected if available. Optional biopsies pre-treatment and 24 hours after first everolimus and carboplatin dose)
- Number of Participants With Toxicity as Measured by NCI CTCAE v3.0 Criteria(Day 1 of each cycle (every 21 days), through study completion, an average of 6 months)
- Pharmacokinetics: Observed Carboplatin AUC Was Estimated Based on the Concentration in the 2.75-h Sample.(Samples were collected Cycle 2, Day 1)
- Overall Survival(After treatment, participants will be contacted every 3 months up to 4 years)
研究者
Elisabeth Heath
Principal Investigator
Barbara Ann Karmanos Cancer Institute