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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Six cycles of chemotherapy comprising: Cabazitaxel 25mg/m2 to be repeated at intervals of 21 days.
Bristol Haematology and Oncology Centre, Horfield Road
Bristol, United Kingdom
Universitty College Hospitals NHS Trust
London, United Kingdom
Complete response
Complete response recorded from the start of the treatment to completion of 6 cy-cles of treatment determined by radiological response assessment
Time frame: 18 weeks
Partial response
Partial response recorded from the start of the treatment to completion of 6 cy-cles of treatment determined by radiological response assessment
Time frame: 18 weeks
Progression free survival
Progression free survival defined as the time from registration to the first of one of the following: development of radiological disease progression (RECIST 1.1) or death from any cause
Time frame: Until patient progresses, which is approximately 6 weeks after randomisation
Overall survival
Overall survival defined as time from registration to the date of death due to from any cause
Time frame: 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).
Acute toxicity (Defined by number of CTCAE v4.03 Adverse Events, Adverse reactions and by grades experienced by the patient collected at study visits and recorded on an Adverse Event Case report form. .
Time frame: 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).
Late toxicity (Defined by number of CTCAE v4.03 Adverse Events, Adverse reactions and by grades experienced by the patient collected at study visits and recorded on an Adverse Event Case report form. .
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Time frame: From 3 months post treatment Cycle 1 Day 1 to up to 6 months recorded at the 3 month and 6 month timepoint.