Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Recurrence

Carcinoma

Penile Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Penile Diseases

Male Urogenital Diseases

Penile Cancer

Six cycles of chemotherapy comprising:

Cabazitaxel 25mg/m2 to be repeated at intervals of 21 days

Six cycles of chemotherapy comprising:

Cabazitaxel 25mg/m2 to be repeated at intervals of 21 days.

Cabazitaxel

Amit Bahl

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.

A Trial of Cabazitaxel Chemotherapy in Relapsed Locally Advanced &/or Metastatic Carcinoma of the Penis

A Phase II Trial of Cabazitaxel Chemotherapy in Relapsed Locally Advanced &/or Metastatic Carcinoma of the Penis

Complete response recorded from the start of the treatment to completion of 6 cy-cles of treatment determined by radiological response assessment

Partial response recorded from the start of the treatment to completion of 6 cy-cles of treatment determined by radiological response assessment

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

Overall survival defined as time from registration to the date of death due to from any cause

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. .

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. .

Spots Global Cancer Trial Database for penile neoplasm