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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: In active follow-up

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, peniletpf-icrctsu@icr.ac.uk

ISRCTN: 78108737

Sponsor: University Hospitals Bristol NHS Foundation Trust and The Institute of Cancer Research

Funding: Cancer Research UK (CRUK/09/001)

Further information 

Further information on the Penile TPF trial may be found on the following sites:

Monthly accrual figures are available from the UK Clinical Trials Gateway

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

Clinical trials

Division of Clinical Studies

The division carries out or coordinates high-quality trials and translational research at both an early phase – typically to test new targeted drugs – and a later stage.

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