A phase II trial of docetaxel, cisplatin and 5-fluorouracil (5-FU) chemotherapy in locally advanced and metastatic carcinoma of the penis

ISRCTN	ISRCTN78108737
DOI	https://doi.org/10.1186/ISRCTN78108737
Secondary identifying numbers	ICR-CTSU/2008/10016

Submission date: 30/01/2008
Registration date: 30/04/2008
Last edited: 26/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/trial-chemotherapy-cancer-penis-penile-tpf

Contact information

Dr Amit Bahl
Scientific

Bristol Haematology & Oncology Centre
Horfield Road
Bristol
BS28ED
United Kingdom

Study information

Study design	Non-randomised controlled trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A phase II trial of docetaxel, cisplatin and 5-fluorouracil (5-FU) chemotherapy in locally advanced and metastatic carcinoma of the penis
Study acronym	Penile TPF
Study objectives	The goal is to determine, in inoperable cancer of the penis, the feasibility and efficacy of giving chemotherapy consisting of two drugs that are known to be active (cisplatin and 5-fluorouracil [5-FU]) with a newer drug, docetaxel. This combination (TPF) has been proven to be highly active in some similar cancers. This is a limited phase II trial to gain insight into the potential activity of this regimen.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Penis cancer
Intervention	All participants will receive the same regimen. The regimen consists of docetaxel 75 mg/m2 day 1 + cisplatin 60 mg/m2 day 1 + 5FU 750 mg/m2 days 1-5 with a cycle of 21 days, three cycles to be given in total prior to formal re-staging.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase I/II
Drug / device / biological / vaccine name(s)	Cisplatin, 5-Fluorouracil, docetaxel
Primary outcome measure	Overall response rate (complete remission rate + partial remission rate). This will be objectively assessed by magnetic resonance imaging (MRI) or computed tomography (CT) scan after completion of the proposed 3 cycles of TPF chemotherapy or at the time of discontinuation of chemotherapy. Scans will be reviewed centrally to confirm outcome.
Secondary outcome measures	1. Proportion of patients with inoperable locoregional disease rendered operable by TPF chemotherapy. Timepoints of measurement not yet defined as of 30 January 2008 2. Progression-free survival. Timepoints of measurement not yet defined as of 30 January 2008. 3. Overall survival. Duration of follow-up not yet defined as of 30 January 2008. 4. Acute toxicity (as determined by Common Toxicity Criteria [CTC]) after each cycle and at 3 months 5. Late toxicity (CTC). Timepoints of measurement not yet defined as of 30 January 2008.
Overall study start date	01/06/2008
Completion date	01/06/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target number of participants	26
Key inclusion criteria	Patients with cancer of the penis fit to receive chemotherapy as palliative or definitive treatment or as treatment on relapse will be eligible. It is expected that the decision to include some groups of patients (e.g., Stage T3, N1 patients) will depend on local policy - discussion within the multidisciplinary Team (MDT) of all eligible patients will be encouraged. Inclusion criteria: 1. Male, >18 years 2. Histologically-proven squamous cell carcinoma of the penis 3. Eligible disease stage: 3.1. M1 3.2. M0, Tx, N3 (i.e. involvement of deep inguinal or pelvic lymph nodes) 3.3. M0, Tx, N2 (i.e. involvement of multiple or bilateral superficial lymph nodes) and deemed inoperable by MDT 3.4. M0, T3 N1 (tumour invades urethra or prostate and single inguinal lymph node involved) 3.5. M0, T4 (tumour invades other adjacent structures) (any N) 4. Glomerular filtration rate (GFR) greater or equal to 60 ml/min 5. Written, informed consent
Key exclusion criteria	1. Pure verrucous carcinoma of the penis 2. Squamous carcinoma of the urethra 3. T1 N1 M0 disease 4. T2 N1 M0 disease 5. T3 N1 M0 where the MDT feels that neoadjuvant chemotherapy is not advisable 6. Unfit for this regimen (as assessed by the MDT) 7. Previous chemotherapy 8. Previous radiotherapy (subsequent radiotherapy for loco-regional consolidation is permitted) 9. Contraindication to chemotherapy
Date of first enrolment	01/06/2008
Date of final enrolment	01/06/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Bristol Haematology & Oncology Centre

Avon
BS2 8ED
United Kingdom

Sponsor information

Sponsor not yet defined (UK)
Not defined

-
-
-
United Kingdom

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	12/11/2013		Yes	No

Editorial Notes

26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
26/05/2016: Publication reference added.