JAVA-P
Research type
Research Study
Full title
A phase II study of Cabazitaxel chemotherapy in relapsed locally advanced and/or metastatic carcinoma of the penis.
IRAS ID
158604
Contact name
Amit Bahl
Contact email
Sponsor organisation
University Hosptial Bristol NHS Foundation trust
Eudract number
2014-002336-14
Research summary
Cancer of the penis is rare in the UK. It is treated with potential of cure by surgery or radiotherapy. However, in some cases the cancer can spread to the lymph nodes (glands) in the adjoining areas including the pelvis (locally advanced) and other areas of the body (metastatic disease). Locally advanced and/or Metastatic cancer of the penis is treated with chemotherapy to control the cancer and potentially improve survival. Whilst the first line chemotherapy in this setting is reasonably well established, however there is no robust data regarding use or effictiveness of any second line chemotherapy.
Cabazitaxel is a new chemotherapy agent which has shown promising activity in laboratory tests on resistant cancer models. It is licensed for use in metastatic prostate cancer after the disease has progressed despite first line chemotherapy.
This study is to evaluate its effectiveness and safety in locally advanced and/or metastatic cancer of the penis which has progressed despite first line chemotherapy.
The aim is to potentially increase the treatment options in this setting.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
14/SC/1156
Date of REC Opinion
11 Aug 2014
REC opinion
Further Information Favourable Opinion