Penile TPF
A phase II Trial of docetaxel, cisplatin & 5-fluorouracil chemotherapy (TPF) in locally advanced and metastatic carcinoma of the penis.
Disease site: Urological
Treatment modality: Chemotherapy
Status: Closed
Trial details
The primary objective of the trial is to determine the activity of combination docetaxel, cisplatin and 5-fluorouracil (TPF) chemotherapy in cancer of the penis.
A total of 29 patients, with histologically-proven squamous cell carcinoma of the penis, were recruited. Patients entered onto the trial received three courses of TPF chemotherapy.
The primary endpoint is overall response rate (complete remission rate + partial remission rate). The secondary endpoints are to determine the proportion of patients with inoperable locoregional disease rendered operable following TPF, to evaluate safety and tolerability, and to assess progression-free and overall survival.
Chief Investigator: Dr Amit Bahl, Bristol Haematology and Oncology Centre.
Co-Chief Investigator: Dr Steve Nicholson, University Hospitals of Leicester
ICR-CTSU Scientific Lead: Dr Emma Hall
Trial management contact: Stephanie Burnett - Trial Manager, [email protected]
ISRCTN: 78108737
Sponsor: University Hospitals Bristol NHS Foundation Trust and The Institute of Cancer Research
Funding: Cancer Research UK (CRUK/09/001)
Further information
View Penile TPF on the National Institute for Health Research website: NIHR - Be Part Of Research
Patient friendly information on the Penile TPF trial at CancerHelp UK
Publications and presentations
Bahl A, Nicholson S, Harland S, Chester J, Pickering L, Barber J, Cruickshank C, Burnett S, Waters R, Hall E, Group obotPTM. A phase II trial of docetaxel, cisplatin, 5-fluorouracil (TPF) in locally advanced and metastatic squamous cell carcinoma (SCC) of the penis (CRUK/09/001). J. Clin. Oncol. 2012;30(Suppl 5):#326
Bahl A, Nicholson A, Harland S, Chester J, Barber J, Cruickshank C, Burnett S, Waters R, Hall E, Group ObotTTM. November, ed. A phase II trial of docetaxel, cisplatin, 5-fluorouracil (TPF) in locally advanced and metastatic squamous cell carcinoma (SCC) of the penis (CRUK/09/001). NCRI National Cancer Conference; 2011; Liverpool.
Bahl A, Nicholson S, Harland S, Chester J, Pickering L, Barber J, Cruickshank C, Burnett S, Waters R, Hall E, Group obotPTM. A phase II trial of docetaxel, cisplatin, 5-fluorouracil (TPF) in locally advanced and metastatic squamous cell carcinoma (SCC) of the penis (CRUK/09/001). Radiother. Oncol. 2011;99(Suppl 1):S507 #7110
Bahl AK, Nicholson S, Barber J, Hall E. A phase II trial of docetaxel, cisplatin, and 5-fluorouracil (TPF) in locally advanced and metastatic carcinoma of the penis (CRUK/09/001). J. Clin. Oncol. 2010;28(15_suppl):TPS240