NCT00190983已完成2 期
A Phase II Evaluation of Pemetrexed (Alimta) in the Treatment of Recurrent Carcinoma of the Cervix
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Tumor Response
研究概览
简要总结
This phase II trial is studying the antitumor activity of single agent pemetrexed 900mg/m2 IV over 10 minutes in patients with recurrent cervical cancer.
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
- •Recurrent squamous or non-squamous cell carcinoma of the cervix with documented disease progression
- •Measurable disease
- •Gynecologic Oncology Group (GOG) performance status 0-2
- •Patients must have received one prior systemic chemotherapy for persistent or recurrent disease
- •Patients with mild to moderate renal insufficiency should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs_ with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of pemetrexed.
- •All patients taking NSAIDs with longer half-lives, should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration.
- •Folic Acid (350-1000 ug) must be given daily beginning approximately 5-7 days prior to first does of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy.
- •Vitamin B12 (1000 ug) will be administered as an intramuscular injection approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9 weeks until 3 weeks after the last dose of study therapy
排除标准
- •Prior Pemetrexed
- •Patients who have received radiation to more than 25% of marrow bearing areas
- •Any evidence of other malignancy within last 5 years, with exception of non-melanoma skin cancer
研究组 & 干预措施
Pemetrexed
Experimental
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 5 years)
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.
次要结局
- Duration of Response(time of initial response until documented tumor progression (up to 5 years))
- Progression-Free Survival(baseline until documented tumor progression (up to 5 years))
- Overall Survival(baseline until death from any cause (up to 5 years))
研究者
研究点 (1)
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