A Phase II Trial of docetaxel, cisplatin and 5FU chemotherapy in locally advanced and metastatic carcinoma of the penis - Penile TPF

Phase 1

• Conditions: ocally advanced and metastatic carcinoma of the penis; MedDRA version: 13.1Level: LLTClassification code 10034299Term: Penile cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2008-000707-28-GB
• Lead Sponsor: The Institute of Cancer Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-16
• Study Completion: 2017-09-27
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 29

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. T3, N1 patients) will depend on local policy – discussion within the MDT of all eligible patients will be encouraged.

Inclusion criteria
• Male, >18 years
• Measurable disease as determined by RECIST criteria
• Histologically-proven squamous cell carcinoma of the penis
• Stage:M1, or;
M0, any T, N3 (i.e. involvement of deep inguinal or pelvic lymph nodes) or;
M0, any T, N2 (i.e. involvement of multiple or bilateral superficial lymph nodes) and deemed inoperable by MDT, or;
M0, T3 N1 (tumour invades urethra or prostate and single inguinal lymph node involved) or;
M0, T4 (tumour invades other adjacent structures) any N
• GFR greater or equal to 60ml/min
• Performance Status ECOG 0, 1 or 2
• Written, informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Pure verrucous carcinoma of the penis
• Squamous carcinoma of the urethra
• Patients who do not have measurable disease as determined by RECIST
• T1 N1 M0 disease
• T2 N1 M0 disease
• Unfit for this regimen (as assessed by the multidisciplinary team)
• Previous chemotherapy
• Previous radiotherapy (subsequent radiotherapy for loco-regional consolidation is permitted)
• Contraindication to chemotherapy
• No malignancy (other than Squamous Cell Carcinoma or Basal Cell Carcinoma of non-penile skin) that has required surgical or non-surgical treatment in the last 5 years. All patients with a previous cancer diagnosis must be discussed with one of the Chief Investigators prior to entry into the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the activity of combination docetaxel, cisplatin and 5FU (TPF) chemotherapy in cancer of the penis and thus determine whether this regimen warrants further research.;Secondary Objective: • To determine the proportion of patients with inoperable locoregional disease rendered operable following TPF<br>• To evaluate safety and tolerability<br>• To assess progression-free and overall survival<br>;Primary end point(s): The primary endpoint is overall response rate (complete remission rate + partial remission rate). This will be objectively assessed by MRI or 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.