A Phase II Trial of Vinflunine chemotherapy in locally-advanced and metastatic carcinoma of the Penis (VinCaP)
- Conditions
- ocally advanced and metastatic carcinoma of the penisMedDRA version: 16.0 Level: PT Classification code 10034299 Term: Penile cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-002592-34-GB
- Lead Sponsor
- The Institute of Cancer Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 22
1. Male, =18 years 2. Measurable disease as determined by RECIST (version 1.1) criteria 3. Histologically-proven squamous cell carcinoma of the penis 4. 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) or; M0, T4 (tumour invades other adjacent structures) any N Notes: a) Patients with M0 disease may be considered if, in the opinion of the specialist MDT, they are deemed unlikely to benefit from surgery with curative intent and unlikely to tolerate combination chemotherapy due to comorbidities and/or disease burden. b)Patients who have received prior radiotherapy to non-target lesions may be included. 5. Pre-treatment blood counts, haematology and biochemistry values within the following acceptable limits: ANC = 1,500/mm3, Platelets =100,000/mm3, GFR = 60ml/min. GFR to be assessed according to local practice (recommended technique of eGFR using the MDRD formula). 6. Performance Status ECOG 0, 1 or 2 7. Written, informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7
1. Pure verrucous carcinoma of the penis 2. Squamous carcinoma of the urethra 3. Patients who do not have measurable disease as determined by RECIST (version 1.1) 4. T1 N1 M0 disease 5. T2 N1 M0 disease 6. M0, T3, N1 (tumour invades urethra or prostate and single inguinal node involved) 7. Unfit for vinflunine chemotherapy(as assessed by the multidisciplinary team) 8. Liver function: Bilirubin =3xULN in the absence of liver metastases and with either transaminases > ULN or GGT > 5xULN 9. Previous chemotherapy or chemoradiotherapy 10. Contraindication to chemotherapy 11. No other 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 the Chief Investigator prior to entry into the trial. 12. Patients who have received radiotherapy to target lesions and have no other lesions that can act as target lesions instead: e.g. Patients with recurrent pelvic lymph nodes that are deemed irresectable and who have had prior radiotherapy to those lymph nodes: i. are INELIGIBLE if the involved lymph nodes are the only site of disease. ii. are ELIGIBLE if they have other measurable sites of disease e.g. pulmonary metastases. If uncertain, please discuss with the Chief Investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method