Condition category
Cancer
Date applied
30/01/2008
Date assigned
30/04/2008
Last edited
26/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Amit Bahl

ORCID ID

Contact details

Bristol Haematology & Oncology Centre
Horfield Road
Bristol
BS28ED
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ICR-CTSU/2008/10016

Study information

Scientific title

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

Acronym

Penile TPF

Study hypothesis

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

Not provided at time of registration

Study design

Non-randomised controlled trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase I/II

Drug names

Cisplatin, 5-Fluorouracil, docetaxel

Primary outcome measures

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 trial start date

01/06/2008

Overall trial end date

01/06/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

26

Participant 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

Recruitment start date

01/06/2008

Recruitment end date

01/06/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Haematology & Oncology Centre
Avon
BS2 8ED
United Kingdom

Sponsor information

Organisation

Sponsor not yet defined (UK)

Sponsor details

-
-
-
United Kingdom

Sponsor type

Not defined

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/PMC3833214

Publication citations

Additional files

Editorial Notes

26/05/2016: Publication reference added.