A Phase II Evaluation of Pemetrexed (Alimta, LY231514l, IND # 40061) in the Treatment of Recurrent or Persistent Platinum Resistant Ovarian or Primary Peritoneal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Tumor Response
研究概览
简要总结
The primary purpose of this trial is to estimate the drug effect on tumors in patients with ovarian or primary peritoneal cancers. Patients will receive Pemetrexed every 21 days until disease progression or unacceptable toxicity. This medication will be given over 10 minutes and may be administered intravenously (IV), through a vein in your arm. Vitamin supplementation is a required part of this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed recurrent or persistent disease ovarian epithelial or primary peritoneal cancer
- •Measurable disease
- •Must have received 1 prior platinum-based (carboplatin, cisplatin, or another organoplatinum compound) chemotherapy regimen for primary disease. Patients who had not received prior paclitaxel may have received a second regimen that included paclitaxel
- •Treatment-free interval < 6 months after prior platinum-based therapy OR progressed during platinum-based therapy
- •Not eligible for a higher priority Gynecologic Oncology Group (GOG) protocol (i.e., any active phase III GOG protocol for the same patient population)
排除标准
- •Patients who have had prior therapy with pemetrexed
- •Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
- •Patients who have received radiation to more than 25% of marrow
研究组 & 干预措施
Pemetrexed
干预措施: pemetrexed (Drug)
结局指标
主要结局
Tumor Response
时间窗: baseline to measured progressive disease (up to 44 months)
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Complete response (CR) = disappearance of all target lesions; Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable disease (SD) = small changes that do not meet above criteria.
次要结局
- Number of Participants With Adverse Events by Grade(every 21-day cycle up to 5 year follow-up)
- Duration of Response(time of initial response until documented tumor progression (up to 44 months))
- Progression-Free Survival(baseline until documented tumor progression (up to 44 months))
- Overall Survival(baseline until death from any cause up to 5-year follow-up)