NCT00786552Unknown2 期
Phase 2 Trial of Pemetrexed (Alimta™) Combined With Paclitaxel in Patients With Recurrent/Advanced Follicular, Papillary or Anaplastic Thyroid Cancer
University Hospital Schleswig-Holstein1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Rate of response
研究概览
简要总结
The aims of this trial are to evaluate the efficacy and tolerability of pemetrexed + paclitaxel in patients with recurrent/advanced follicular, papillary or anaplastic thyroid 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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of metastatic, histologically proven follicular/papillary or anaplastic thyroid cancer without clinically meaningful surgical or radiotherapeutic options and/or no amenability for radio-iodine therapy and evidence of progressive or symptomatic disease.
- •No other forms of chemotherapy or investigational anticancer agents therapy for at least 4 weeks before enrollment in study.
- •Performance status of 0 to 2 on the ECOG scale.
- •Evidence of measurable disease according to the RECIST criteria.
- •Prior radiation therapy and surgery allowed if completed at least 2 weeks prior to study enrollment, prior radioiodine treatment at least 3 months prior to study enrollment and patients must have recovered from the acute toxic effects of the treatment prior to study entry.
- •Adequate organ function.
- •No active infection (at the discretion of the investigator) or current central nervous system (CNS) metastases or history of central nervous system metastases or other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
- •No breast feeding nor pregnancy. For women of childbearing potential a negative serum pregnancy-test has to be performed 7 days prior to inclusion into the study.
- •No coexisting second malignancy or history of prior malignancy within the last 5 years. (Excluding basal or squamous cell carcinoma of the skin, superficial bladder cancer and in situ carcinoma of the cervix with no evidence of recurrence).
- •For men and women of childbearing potential appropriate contraceptive precautions should be taken during the trial and for 3 months afterwards.
- •No significant cardiovascular disease in the form of abnormal electrocardiogram (ECG) coupled with clinical features of recent or recurrent symptomatic cardiac disease (including myocardial infarction within the last year, uncontrolled angina, arrhythmia or hypertension, severe congestive heart failure (NYHA >3)).
- •No evidence of peripheral neuropathy greater than CTC Grade
- •No prior taxane and/or pemetrexed therapy.
- •Ability to discontinue administration of acetysalicylate and other nonsteroidal anti-inflammatory agents (NSAID) for 2 days before, the day of, and 2 days after the dose of pemetrexed (5 days prior for long-acting agents such as piroxicam). Exceptions for selective cyclooxygenase II-inhibitors in analgesic treatment may be discussed.
- •No clinically significant effusions (pleural or peritoneal), or albumin <2.5 g/dl at the time of study treatment application. The drainage of effusions prior to study treatment application is possible.
- •Inability of oral intake of folic acid or intramuscular vitamin B12 supplementation.
- •At least 18 years of age and absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
- •Participation in another trial at the same time is not allowed.
排除标准
- 未提供
研究组 & 干预措施
chemotherapy
Experimental
干预措施: pemetrexed + paclitaxel (Drug)
结局指标
主要结局
Rate of response
时间窗: 6 weeks
次要结局
- Toxicity(weekly)
研究者
研究点 (1)
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