Relapsed, locally advanced and/or metastatic carcinoma of the penis. MedDRA version: 17.0 Level: PT Classification code 10007384 Term: Carcinoma in situ of penis System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Jevtana
Product Name: Cabazitaxel
Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion
INN or Proposed INN
Sponsors
University Hosptial Bristol NHS Foundation trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Written informed consent Male = 18 years Histologically proven squamous cell carcinoma of the penis Stage: M1 or M0 Tx N3 or M0 Tx N2 and deemed inoperable by MDT or M0 T3 N1 or M0 T4 any N ECOG =2 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: o Neutrophils =1.5 x 109/L o Haemoglobin =10 g/dL o Platelets =100 x 109/L o Total bilirubin =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 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 ECOG > 2 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the activity of Cabazitaxel chemotherapy in relapsed cancer of the penis as assessed by objective response rate.;Primary end point(s): To determine the activity of Cabazitaxel chemotherapy as assessed by objective response rate; Secondary Objective: To evaluate the safety and tolerability of Cabazitaxel To assess prgression free survival To assess overall survival To evaluate the frequency, severity and relatedness of any adverse events To asess acute toxicity To asess late toxicity To asess quality of life ; Timepoint(s) of evaluation of this end point: Response will be evaluated according to radiological response as per RECIST 1.1. The objective response rate for this study is defined as the proportion of patients having achieved partial or complete remission according to their radiological stage at end of cycle 6 compared with radiological stage at diagnosis. Analysis will include tabulation of baseline characteristics of recruited patients. Intention to treat analysis will be used. Baseline characteristics for those patients not completing trial treatment will be tabulated for comparison with treated patients, to ensure the ability to generalise results. Baseline characteristics will include (but are not limited to) demographic data, tumour stage and grade. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and tolerability Progression free survival Overall survival ; Timepoint(s) of evaluation of this end point: Progression free survival will be calculated from the date of study entry until a progression occurs. Progression events are defined as clinical, pathologic or radiological documented disease progression, or death from any cause, Patients free from a progression event will be censored on the date of last follow up. A progression-free survival curve will be generated using the methods of Kaplan and Meier. All patients registered in the study will be included. Median PFS rate will be reported with 95% CIs. Duration of response as measured by Kaplan-Meier at each follow-up, or until progression, will be reported. | — |
Countries
United Kingdom
Contacts
Public ContactSylvia Pearson
University Hospitals Bristol NHS Foundation trust
Outcome results
None listed