Randomized Phase II Study of Paclitaxel Plus Metformin or Placebo for the Treatment of Platinum-refractory, Recurrent or Metastatic Head and Neck Neoplasms
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Disease control at week 12
研究概览
简要总结
Metformin plus paclitaxel for recurrent or metastatic head and neck cancer: a randomized phase II trial
详细描述
METTAX is a phase II randomized trial that aim to evaluate the addition of metformin to paclitaxel in patients that failed to curative-intent treatment for Head-and neck neoplasms.
Patients eligible for this protocol will be randomized to paclitaxel 175mg/m2 plus metformin or placebo until disease progression or unacceptable toxicity. The primary end-point is disease control (complete response, partial response or stable disease, according to RECIST 1.1) in the 12th week. Secondary end-points are PFS, OS, response rate and safety. Molecular markers in samples collected before and under treatment will be tested for correlation with clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •18 years or older
- •Biopsy-proven head and neck squamous cell carcinoma
- •Ineligibility for curative intent therapy, e.g., surgery or radiation therapy
- •recurrent or stage IV disease
- •previous failure to platinum-based chemotherapy
- •measurable disease according to RECIST v1.1
- •PS ECOG 0-2
排除标准
- •known hypersensitivity to metformin or paclitaxel
- •SNC metastasis
- •Acute or chronic infection
研究组 & 干预措施
Paclitaxel plus metformin
Paclitaxel 175mg/m² q21d + metformin up to 2500mg/d until disease progression, prohibitive toxicity or consent withdrawal
干预措施: metformin up to 2500mg/d (Drug)
Paclitaxel, placebo
Paclitaxel 175mg/m² q21d until disease progression, unacceptable toxicity or consent withdrawal
干预措施: paclitaxel 175mg/m² q21d (Drug)
Paclitaxel plus metformin
Paclitaxel 175mg/m² q21d + metformin up to 2500mg/d until disease progression, prohibitive toxicity or consent withdrawal
干预措施: paclitaxel 175mg/m² q21d (Drug)
Paclitaxel, placebo
Paclitaxel 175mg/m² q21d until disease progression, unacceptable toxicity or consent withdrawal
干预措施: placebo (Drug)
结局指标
主要结局
Disease control at week 12
时间窗: 12th week
Number of subjects at week 12 with complete response, partial response or stable disease, over the total number of subjects, for each arm. Disease control means complete response, partial response or stable disease, according to RECIST 1.1.
次要结局
- Progression-free survival(6mo after the last patient recruited)
- Overall Survival (subjects without death (any cause))(6mo after the last enrolled patient)
- Number of patients with Grade 3-5 Adverse Events in each arm, for each category of AE(6 mo after the last enrolled patients)
研究者
Lucas Vieira dos Santos
Dr
Barretos Cancer Hospital