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 |
| Protocol serial number | ICR-CTSU/2008/10016 |
| Sponsor | Sponsor not yet defined (UK) |
| Funder | Cancer Research UK |
- 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
Plain English summary of protocol
http://cancerhelp.cancerresearchuk.org/trials/trial-chemotherapy-cancer-penis-penile-tpf
Contact information
Scientific
Bristol Haematology & Oncology Centre
Horfield Road
Bristol
BS28ED
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised controlled trial |
| Secondary study design | Non randomised study |
| Study type | Participant 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 |
| Phase | Phase I/II |
| Drug / device / biological / vaccine name(s) | Cisplatin, 5-Fluorouracil, docetaxel |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. Proportion of patients with inoperable locoregional disease rendered operable by TPF chemotherapy. Timepoints of measurement not yet defined as of 30 January 2008 |
| Completion date | 01/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
BS2 8ED
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/11/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes |
Editorial Notes
26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
26/05/2016: Publication reference added.
