Locally advanced and metastatic carcinoma of the penis MedDRA version: 16.0 Level: PT Classification code 10034299 Term: Penile cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Javlor
Product Name: Vinflunine
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Vinflunine
C
Sponsors
The Institute of Cancer Research
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal research objective of the VinCaP study is to determine the clinical benefit and toxicity of Vinflunine chemotherapy in inoperable cancer of the penis and thus determine whether this drug warrants further research in this indication.;Secondary Objective: The secondary research questions for the VinCap study are: • To assess the objective response rate (complete response and partial response); • To evaluate safety and tolerability; • To assess progression-free and overall survival.;Primary end point(s): Primary: The primary endpoint is clinical benefit (objective response + stable disease rate) measured after four cycles of vinflunine chemotherapy.;Timepoint(s) of evaluation of this end point: Clinical Benefit: The clinical benefit rate is defined as the proportion of patients having achieved partial remission, complete remission or stable disease according to RECIST criteria (v1.1) on imaging and/ or bi-dimensional clinical measurements (of skin disease) performed after 4 cycles (approximately 11-12 weeks from Day 1 of first cycle).All scans will be reviewed centrally. The clinical benefit rate will be presented along its 95% CI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Objective response rate (complete response and partial response) • Toxicity; • Progression-free survival; • Overall survival; • Treatment compliance.;Timepoint(s) of evaluation of this end point: Secondary Endpoints • Objective response rate defined as the proportion of patients having achieved partial or complete remission. • Toxicity will be evaluated, using the CTCAE v4 scoring, after each cycle, at the end of treatment and follow up visits. • Progression-free survival defined as time from registration until the first of clinically or radiologically documented disease progression, or death from any cause death. • Overall survival will be defined as the time from registration until death from any cause. • Treatment Compliance will be defined as proportion of planned doses delivered. | — |
Countries
United Kingdom
Contacts
Public ContactStephanie Burnett
The Institute of Cancer Research
Outcome results
None listed