NCT02223884已完成2 期
A Study to Evaluate the Efficacy of Docetaxel and Carboplatin in Metastatic Malignant Melanoma Failed First-Line Dacabazine or Temozolomide Contained Therapy
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
- 30
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
This is the phase II, single-arm, single-center study assessing the efficacy of weekly docetaxel plus carboplatin in second-line treatment of malignant melanoma (unresectable or metastatic) who has failed dacarbazine or temozolomide contained therapy. The primary end point is overall response rate according to RECIST 1.1 criteria assessed using CT or MRI and secondary end point includes disease control rate, progression free survival, overall survival and safety.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically proven malignant melanoma (recurred or metastatic) that had progressed during or after receiving at least one cycle of a regimen containing dacarbazine or temozolomide in the advanced setting
- •Measurable disease (RECIST)
- •ECOG performance 0-2
- •Adequate organ function
- •Total bilirubin <1.5N ; ASAT and ALAT <2.5N
- •Serum Creatinin < 1.5N
- •ANC ≥ 1,500/mm³ (G-CSF allowed)
- •Platelets ≥ 100,000/mm³
- •Hb ≥ 9.0 g/dL
- •Life expectancy of at least 12 weeks
- •Signed Written Informed Consent
排除标准
- •Symptomatic brain metastasis
- •Previous history of treatment with taxane or platinum agent containing chemotherapy
- •Previous major surgery within 2 weeks before the start of the trial, or a failure to recover from the surgery
- •Previous history of other malignancies within 5 years except for cured skin basal cell carcinoma or cured in-situ cervix cancer
- •Other severe medical conditions (infection, uncontrolled hypertension, heart failure, MI history within 6 months)
- •Sensitivity to platinum agents or docetaxel
- •Uncontrolled seizure
- •Women pregnant or nursing
- •Alcohol or drug abuser
研究组 & 干预措施
weekly docetaxel and carboplatin
Experimental
干预措施: docetaxel 35mg/m2 (Drug)
weekly docetaxel and carboplatin
Experimental
干预措施: Carboplatin AUC3 (Drug)
结局指标
主要结局
Response Rate
时间窗: every 6 weeks, up to 4 year
Response rate evaluation based on RECIST 1.1 confirmed by CT or MRI
次要结局
- adverse events(every 6 weeks, up to 4 year)
- disease control rate(every 6 weeks, up to 4 year)
- progression free survival(every 6 weeks, up to 4 year)
- overall survival(every 6 weeks, up to 4 year)
研究者
研究点 (1)
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