A Prospective Phase 2 Study of PEmetrexed in Combination With Cisplatin in Patients With Advanced UrotheLIal CAnceR
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
Pemetrexed has demonstrated a favorable response with minimal toxicity when used as single agent as first-line and second-line treatment for advanced urothelial carcinoma. The response rates were 32% and 28% for the first-line and second-line setting, respectively. Cisplatin is one the most active chemotherapeutic agents in urothelial cancer, frequently used as combination chemotherapy such as GP (gemcitabine plus cisplatin) or MVAC (methotrexate, vinblastine, adriamycin, and cisplatin).
Pemetrexed and cisplatin showed favorable activity profile in advanced non-small cell lung cancer with highly favorable toxicity profile.
This study is to assess the efficacy and safety of pemetrexed plus cisplatin in advanced urothelial carcinoma.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic diagnosis of urothelial (transitional cell) carcinoma with the exception of micropapillary subtype
- •Patients must have recurrent disease (locally advanced or metastatic) that is not amenable to local therapy or newly diagnosed distant metastatic disease
- •Measurable disease defined by RECIST v.1.0
- •ECOG performance status of 2 or better
- •Adequate organ and bone marrow function defined as
排除标准
- •Other tumor type than urothelial carcinoma
- •Presence or history of CNS metastasis
- •Prior systemic chemotherapy or immunotherapy (but prior local intravesical chemotherapy or immunotherapy was allowed. And recurrent disease after adjuvant or neoadjuvant cisplatin-based systemic chemotherapy is allowed if the last chemotherapy was administered 1 year or more before the patient enrollment.)
- •Presence of second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
- •Peripheral sensory neuropathy grade 2 or worse
- •Other serious illness or medical conditions
研究组 & 干预措施
PemCis
Pemetrexed plus Cisplatin
干预措施: Pemetrexed (Drug)
PemCis
Pemetrexed plus Cisplatin
干预措施: Cisplatin (Drug)
PemCis
Pemetrexed plus Cisplatin
干预措施: Dexamethasone (Drug)
PemCis
Pemetrexed plus Cisplatin
干预措施: Vitamins (Drug)
结局指标
主要结局
Response rate
时间窗: 12 months
Based on RECIST v.1.0
次要结局
- Overall survival(12 months)
- Safety(8 months)
- Progression-free survival(12 months)
研究者
JLee
Associate Professor
Asan Medical Center