Clinical trial NCT02057913: A Phase II Trial of Vinflunine Chemotherapy in Locally-advanced and Metastatic Carcinoma of the Penis (VinCaP)
Official title: A Phase II Trial of Vinflunine Chemotherapy in Locally-advanced and Metastatic Carcinoma of the Penis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Locally-advanced or Metastatic Penile Neoplasms
Keywords: Penile neoplasms
Chemotherapy
Vinflunine
Phase II
Lead sponsor: Institute of Cancer Research, United Kingdom
Sponsor class: OTHER
Collaborators: name: St George's Healthcare NHS Trust
First posted: 2014-02-07
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: VinCaP is a multicentre single-arm phase II trial. 22 patients will receive Vinflunine chemotherapy (Vinflunine 320mg/m2 given intravenously on day 1 of each cycle of 21 days, four cycles to be given prior to formal re-staging).


Eligibility criteria: Inclusion Criteria:

1. Male, ≥18 years.
2. Measurable disease as determined by RECIST (Response Evaluation Criteria in Solid Tumors) criteria (version 1.1).
3. Patients who present with purely cutaneous measurable disease should fulfill RECIST Criteria (see Appendix 1). Lesions should be a minimum size of 10 mm and measured using calipers by clinical examination.
4. Histologically-proven squamous cell carcinoma of the penis.
5. 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:
   1. Patients with M0 disease may be considered if, in the opinion of the specialist Multi Disciplinary Team (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.
   2. Patients who have received prior radiotherapy to non-target lesions may be included.
6. Pre-treatment blood counts, haematology and biochemistry values within the following acceptable limits: Absolute Neutrophil Count (ANC) ≥ 1,500/mm3, Platelets ≥100,000/mm3, glomerular filtration rate (GFR) ≥60ml/min. GFR to be assessed according to local practice (recommended technique of eGFR using the MDRD formula.
7. Liver function: Patients must have (with or without the presence of liver metastases):

   * A prothrombin time \>70% normal value (NV) AND
   * Bilirubin \<1.5xUpper Limit of Normal (ULN) AND
   * Transaminases \<2.5xULN AND
   * GGT \<5xULN
8. Performance Status Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2.
9. Written, informed consent.

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. Previous chemotherapy or chemoradiotherapy.
9. Contraindication to chemotherapy.
10. 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 the Chief Investigator prior to entry into the trial.
11. 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.

Primary outcomes:
measure: Clinical Benefit
timeFrame: 12 weeks
Secondary outcomes:
measure: Objective Response Rate
timeFrame: 12 weeks
measure: Toxicity
timeFrame: Baseline, 3, 6, 9, 12 weeks on treatment, and at follow-up, 3, 6, 9, 12, 18, 24 months (timed from end of last cycle of chemotherapy)
measure: Progression-free survival
timeFrame: From registration to first documented disease progression or death from any cause, up to 24 months
measure: Overall Survival
timeFrame: Time from registration until death from any cause, up to 24 months
measure: Treatment Compliance
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Whitchurch
country: United Kingdom
facility: Velindre NHS Trust
state: Cardiff
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals NHS Trust
state: Cornwall
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
state: Greater London
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
state: Greater Manchester
city: Tooting
country: United Kingdom
facility: St George's Healthcare NHS Trust
state: London
city: Wirral
country: United Kingdom
facility: Clatterbridge Centre for Oncology NHS Foundation Trust
state: Merseyside
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
Study officials:
affiliation: St George's Healthcare NHS Trust
name: Lisa Pickering, MBBS, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nicholson S, Tovey H, Elliott T, Burnett SM, Cruickshank C, Bahl A, Kirkbride P, Mitra AV, Thomson AH, Vasudev N, Venugopal B, Slade R, Tregellas L, Morgan B, Hassall A, Hall E, Pickering LM. VinCaP: a phase II trial of vinflunine in locally advanced and metastatic squamous carcinoma of the penis. Br J Cancer. 2022 Jan;126(1):34-41. doi: 10.1038/s41416-021-01574-9. Epub 2021 Oct 20.