A phase II study of Cabazitaxel chemotherapy in relapsed locally advanced and/or metastatic carcinoma of the penis. - JAVA-P

niversity Hosptial Bristol NHS Foundation trust0 个研究点目标入组 9 人开始时间: 2014年9月8日最近更新: 2019年6月30日

试验速览

暂无简介。

•Written informed consent
•Male = 18 years
•Histologically proven squamous cell carcinoma of the penis
•M0 Tx N3 or
•M0 Tx N2 and deemed inoperable by MDT or
•M0 T3 N1 or
•M0 T4 any N
•Previous frist line chemotherapy with either TPF (Docetaxel, Cisplatin and 5 Flurouracil) or Cisplatin + 5FU
•Measurable disease
•Adequate organ function as evidenced by the following peripheral blood counts and serum biochemistry at enrolment:
•oNeutrophils =1.5 x 109/L
•oHaemoglobin =10 g/dL
•oPlatelets =100 x 109/L
•oTotal bilirubin <1.5 upper limit of normal (ULN)
•oAlanine 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 17
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•Pure verrucous carcinoma of the penis
•Squamous cell carcinoma of the penis
•T1 N1 M0 disease
•T2 N1 M0 disease
•Unfit for this regimen as assessed at MDT
•Contraindication to chemotherapy
•Active peripheral neuropathy grade = 2
•Active secondary cancers
•Other concurrent serious illness or medical condition
•Inadequate organ function
•ECG evidence of uncontrolled cardiac arrythmias, angina pectoris and/or hypertension, history of congestive heart failure or myocardial infarctoin within the 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
•Particpation in another clinical trial with an investigational drug within 30 days prior to study registration
•Concurrent or planned treatment with strong inhibitors of cytochrome P450 3A4/5. 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 3A4/5.A 1 week washout period is necessary for patients who are already on these treatments

发起方

niversity Hosptial Bristol NHS Foundation trust