NCT00190918已完成2 期
A Phase II Trial of Pemetrexed (Alimta) in the Treatment of Recurrent or Persistent Low Risk Gestational Trophoblastic Tumor
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To determine the activity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients
研究概览
简要总结
This phase II study is evaluating the activity of Pemetrexed in patients diagnosed with low risk Gestational Trophoblastic Tumor (GTT) that have failed prior treatment.
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
- •Persistent or recurrent low risk Gestational Trophoblastic Tumor (GTT)
- •WHO score 2-6 (re-evaluated at the time of relapse
- •Histologically confirmed complete or partial moles on initial evacuation
- •Patients with mild to moderate renal insufficiency should avoid taking 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 micrograms) must be given daily beginning approximately 5-7 days prior to first dose of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy.
- •Vitamin B12 (1000 micrograms) 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
- •Previous treatment that included chemotherapy other than actinomycin -D or methotrexate (+/- folinic acid).
- •Patients with more than 8 metastatic lesions identified
- •Patients with metastases to liver, spleen, brain, kidney or GI tract
结局指标
主要结局
To determine the activity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients
次要结局
- To determine the toxicity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients
研究者
研究点 (1)
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