A Phase II Study of Pemetrexed (Alimta) as Second-Line Therapy for Hormone Refractory Prostate Cancer: Hoosier Oncology Group GU03-67
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 15
- 主要终点
- Best Overall PSA Response
研究概览
简要总结
Docetaxel-based therapy has been shown to prolong survival as first-line therapy for patients with hormone refractory prostate cancer (HRPC), and has become the standard of care. The beneficial effects of any therapy in HRPC may be diverse and include reduction in tumor bulk (when measurable), reduction in prostate-specific antigen PSA, reduction in symptoms (particularly pain), or stabilization of disease. Clear reductions in tumor bulk or PSA may provide objective evidence of a treatment effect, and stabilization of disease may be just as clinically meaningful in patients who are actively progressing prior to starting therapy. Pemetrexed has shown a broad array of activity in many diseases that until now were thought to be non-responsive to chemotherapy in the second-line setting.
This trial is designed to further assess the efficacy, safety, tolerability, and pharmacogenetics of pemetrexed as a single agent in subjects with HRPC whose disease has progressed following one prior taxane-based chemotherapy regimen for HRPC.
详细描述
OUTLINE: This is a multi-center study.
- Pemetrexed 500mg/m2 will be administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle.
- Folic Acid (350-1000 mcg. PO daily) will be taken by patients to reduce toxicity. At least 5 daily doses of folic acid must be taken during the 7-day period preceding the first dose of pemetrexed, and dosing should continue during the full course of therapy and for 21 days after the last dose of pemetrexed.
- Vitamin B12 (1000 µg) will be administered as an intramuscular injection during the week preceding the first dose of pemetrexed and every 3 cycles thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed.
Performance Status: Karnofsky Performance Status 70-100
Life expectancy > 12 weeks
Hematopoietic:
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 documented adenocarcinoma of the prostate
- •Clinically refractory or resistant to hormone therapy as assessed by progression following at least one hormonal therapy (orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist)
- •One prior taxane based chemotherapy regimen for HRPC
- •Documented progression of disease after one taxane based prior chemotherapy regimen for HRPC. Progression is defined as at least one of the following:
- •An increase in PSA > 50% over nadir value on prior Taxane-based therapy
- •Progression of measurable disease as defined by RECIST
- •Progression of bone disease as defined by the appearance of one or more new bone lesions or worsening symptoms
- •Orchiectomy or testosterone levels < 50 ng/dL maintained by LHRH agonist
- •Prior chemotherapy, or other experimental anticancer agents must be completed > 4 weeks prior to being registered for protocol therapy
- •Palliative radiotherapy must be completed at least 14 days prior to registration.
排除标准
- •Intravenous radio-isotopes therapy must be completed at least 6 weeks prior to registration
- •No brain metastasis that are untreated and/or not controlled and/or still requiring corticosteroids
- •No history of other malignancies within 5 years prior to being registered for protocol therapy, except for adequately treated basal or squamous cell skin cancer
- •No history of uncontrolled psychiatric illness or serious systemic disease, including active infection, uncontrolled hypertension
- •No surgery or significant traumatic injury within 21 days prior to being registered for protocol therapy
- •Patients must be willing to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (8 day period for long acting agents such as piroxicam)
- •Patients must be willing to take folic acid or vitamin B12 supplementation
研究组 & 干预措施
Investigational Treatment
- Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
- Oral Folic Acid, once per day for 7 days preceding pemetrexed dose, continued daily, and for 21 days after the last dose of pemetrexed.
- Vitamin B12, 1000ug intramuscular injection 7 days preceding pemetrexed dose, and every three cycles thereafter on the same day of pemetrexed administration
干预措施: Pemetrexed (Drug)
Investigational Treatment
- Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
- Oral Folic Acid, once per day for 7 days preceding pemetrexed dose, continued daily, and for 21 days after the last dose of pemetrexed.
- Vitamin B12, 1000ug intramuscular injection 7 days preceding pemetrexed dose, and every three cycles thereafter on the same day of pemetrexed administration
干预措施: Folic Acid (Dietary Supplement)
Investigational Treatment
- Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle
- Oral Folic Acid, once per day for 7 days preceding pemetrexed dose, continued daily, and for 21 days after the last dose of pemetrexed.
- Vitamin B12, 1000ug intramuscular injection 7 days preceding pemetrexed dose, and every three cycles thereafter on the same day of pemetrexed administration
干预措施: Vitamin B12 (Dietary Supplement)
结局指标
主要结局
Best Overall PSA Response
时间窗: Start of treatment until disease progression/recurrence (for life)
Best overall Prostate-Specific Antigen (PSA) response PSA response is defined by a greater than or equal to 50% decline in PSA confirmed by a second PSA value at least 4 weeks after the first PSA response timepoint PSA Stable Disease is defined as less than a 50% decline in PSA and less than a 50% increase in PSA from baseline PSA progression is defined as greater than or equal to a 50% increase in PSA compared to baseline
次要结局
- Overall Survival(From study enrollment until death (for life))
- Rate of Clinical Benefit(Any time among evaluable subjects (for life))
- OBJECTIVE Overall Response Rate(Start of treatment until disease progression/recurrence (for life))
- Safety and Tolerability(18 months)
- Time to Prostate-Specific Antigen (PSA)/Serological Progression(From study enrollment to progression per PSA criteria (for life))
- RFC1 G80A Genotype(Screening)
- Time to Progression(Study enrollment until progression per RECIST or PSA (for life))
研究者
Christopher Sweeney, MBBS
Sponsor-Investigator
Hoosier Cancer Research Network