Penile TPF

• Research type

  Research Study

• Full title

  A Phase II Trial of docetaxel, cisplatin and 5FU chemotherapy in locally advanced and metastatic carcinoma of the penis

• Sponsor organisation

  The Institute of Cancer Research

• Eudract number

  2008-000707-28

• ISRCTN Number

  ISRCTN78108737

• Research summary

  Cancer of the penis is rare, accounting for 0.4-0.6% of male malignancies, and with an incidence of 1 in 100,000 and around 300 new cases/year in England and Wales. The rarity of penile cancers means there are very few prospective clinical trials investigating the management of such tumours. The aim of this trial is to determine, in inoperable cancer of the penis, the feasibility and activity of giving chemotherapy consisting of two drugs that are known to be active (Cisplatin and flurouracil) with a newer drug, Docetaxel. This combination (TPF) has been proven to be highly active in some similar cancers.It is also aimed to determine the proportion of patients with inoperable locoregional disease that are now operable following TPF chemotherapy. We will also aim to assess how safe and tolerable it is to give this chemotherapy regimen. In addition we will assess progression-free and overall survival of patients who receive this chemotherapy regimen.This study is not randomised. This study is to gain insight into the potential activity of this regimen. 26 patients will receive the following regimen: docetaxel 75mg/m2 day 1, cisplatin 60mg/m2 day 1, flurouracil 750mg/m2/day (day 1-5), with a cycle of 21 days, three cycles to be given in total prior to formal assessment of their response to the chemotherapy.

• REC name

  London - Central Research Ethics Committee

• REC reference

  08/H0718/78

• Date of REC Opinion

  23 Mar 2009

• REC opinion

  Further Information Favourable Opinion