A Phase II Trial of Cabazitaxel Chemotherapy in Relapsed Locally Advanced &/or Metastatic Carcinoma of the Penis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Complete response
研究概览
简要总结
An evaluation of the activity of cabazitaxel chemotherapy in relapsed cancer of the penis. Safety and tolerability will be monitored and survival will be assessed. It is hypothesised that cabazitaxel is useful in increasing progression free survival in relapsed penile cancer.
详细描述
First line treatment of penile cancer often combines Docetaxel, Cisplatin and 5Fluouracil (5FU) and there is currently no United Kingdom standard second line agent. Carbazitaxel has been shown to kill both taxane resistant and sensitive cells. JAVA-P is a phase two, single arm study of the use of carbazitaxel for relapsed, locally advanced or metastatic carcinoma of the penis. Seventeen patients will be recruited over two years, with adverse events and progression free survival being assessed. Results may indicate the need for larger studies to evaluate carbazitaxel as a first line agent.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically-proven squamous cell carcinoma of the penis
- •Performance status ECOG 0-2
- •Written informed consent
- •Measurable disease as per RECIST 1.1
- •Fit to receive cabazitaxel as second line chemotherapy
- •Previously received TPF or cisplatin-5FU as first line systemic chemotherapy for penile cancer
- •Adequate organ function as evidenced by the following peripheral blood counts and serum biochemistry at enrollment:
- •Neutrophils ≥1.5 x 109/L
- •Haemoglobin ≥10 g/dL
- •Platelets ≥100 x 109/L
- •Total bilirubin <1.5 upper limit of normal (ULN)
- •Alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT) ≤1.5 x ULN
- •Serum creatinine ≤1.5 x ULN. (If creatinine is 1.0-1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with a creatinine clearance <60 ml/min should be excluded.)
排除标准
- •Pure veruccous carcinoma of the penis
- •Squamous carcinoma of the urethra
- •T1 N1 M0 disease
- •T2 N1 M0 disease
- •Unfit for this regimen (as assessed by the multidisciplinary team)
- •Contraindication to chemotherapy
- •ECOG Performance Status > 2
- •Active Grade ≥2 peripheral neuropathy
- •Active secondary cancers
- •Other concurrent serious illness or medical conditions
- •Electrocardiogram (ECG) evidence of uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension, history of congestive heart failure, or myocardial infarction within last 6 months.
- •Uncontrolled diabetes mellitus.
- •History of severe hypersensitivity reaction (≥grade 3) to docetaxel
- •History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs
- •Active infection requiring systemic antibiotic or anti-fungal medication
- •Participation in another clinical trial with any investigational drug within 30 days prior to study registration.
- •Concurrent or planned treatment with strong inhibitors of cytochrome P450 3A4/
- •A 1-week washout period is necessary for patients who are already on these treatments.
- •Concurrent or planned treatment with strong inducers of cytochrome P450 3A4/
- •A 1-week washout period is necessary for patients who are already on these treatments.
研究组 & 干预措施
Cabazitaxel
Six cycles of chemotherapy comprising:
Cabazitaxel 25mg/m2 to be repeated at intervals of 21 days
干预措施: Cabazitaxel (Drug)
结局指标
主要结局
Complete response
时间窗: 18 weeks
Complete response recorded from the start of the treatment to completion of 6 cy-cles of treatment determined by radiological response assessment
Partial response
时间窗: 18 weeks
Partial response recorded from the start of the treatment to completion of 6 cy-cles of treatment determined by radiological response assessment
次要结局
- Overall survival(Until patient dies, which is approximately 3 months after randomisation)
- Acute toxicity (Defined by number of CTCAE v4.03 Adverse Events, Adverse Reactions and by grades and the worst grade).(After each cycle (every 3 weeks) for maximally 6 cycles therefore 18 weeks whilst on treatment and at the 3 month visit timepoint)
- Late toxicity (Defined by number of CTCAE v4.03 Adverse Events, Adverse Reactions and by grades and the worst grade).(From 3 months post treatment Cycle 1 Day 1 to up to 6 months recorded at the 3 month and 6 month timepoint.)
- Progression free survival(Until patient progresses, which is approximately 6 weeks after randomisation)