NCT02057913

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

March 17, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2018

Completed
Last Updated

July 23, 2020

Status Verified

August 1, 2018

Enrollment Period

4.6 years

First QC Date

February 5, 2014

Last Update Submit

July 22, 2020

Conditions

Locally-advanced or Metastatic Penile Neoplasms

Keywords

Penile neoplasmsChemotherapyVinfluninePhase II

Outcome Measures

Primary Outcomes (1)

  • Clinical Benefit

    To determine the clinical benefit (objective response \& stable disease rate) and toxicity of vinflunine in patients with inoperable (locally advanced or metastatic) cancer of the penis and thus determine whether this drug warrants further research in this indication.

    12 weeks

Secondary Outcomes (5)

  • Objective Response Rate

    12 weeks

  • Toxicity

    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)

  • Progression-free survival

    From registration to first documented disease progression or death from any cause, up to 24 months

  • Overall Survival

    Time from registration until death from any cause, up to 24 months

  • Treatment Compliance

    12 weeks

Study Arms (1)

Vinflunine

EXPERIMENTAL

All patients will receive on Day 1 of a 21 day cycle, vinflunine 320mg/m2 via intravenous infusion in either 100ml sodium chloride 0.9% or glucose 5% over 20 minutes; four cycles to be given in total prior to formal re-staging.

Drug: Vinflunine

Interventions

VinflunineDRUG

All patients will receive on Day 1 of a 21 day cycle, vinflunine 320mg/m2 via intravenous infusion in either 100ml sodium chloride 0.9% or glucose 5% over 20 minutes; four cycles to be given in total prior to formal re-staging.

Also known as: Javlor
Vinflunine

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male, ≥18 years.
  • Measurable disease as determined by RECIST (Response Evaluation Criteria in Solid Tumors) criteria (version 1.1).
  • 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.
  • 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) or; M0, T4 (tumour invades other adjacent structures) any N.
  • Notes:
  • 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.
  • Patients who have received prior radiotherapy to non-target lesions may be included.
  • 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.
  • 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
  • Performance Status Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2.
  • +1 more criteria

You may not qualify if:

  • Pure verrucous carcinoma of the penis.
  • Squamous carcinoma of the urethra.
  • Patients who do not have measurable disease as determined by RECIST (version 1.1).
  • T1 N1 M0 disease.
  • T2 N1 M0 disease.
  • M0, T3, N1 (tumour invades urethra or prostate and single inguinal node involved).
  • Unfit for vinflunine chemotherapy (as assessed by the multidisciplinary team).
  • Previous chemotherapy or chemoradiotherapy.
  • Contraindication to chemotherapy.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Velindre NHS Trust

Whitchurch, Cardiff, CF14 2TL, United Kingdom

Location

Royal Cornwall Hospitals NHS Trust

Truro, Cornwall, TR1 3LJ, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, Greater London, NW1 2PG, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, Greater Manchester, M20 4BX, United Kingdom

Location

St George's Healthcare NHS Trust

Tooting, London, SW17 0QT, United Kingdom

Location

Clatterbridge Centre for Oncology NHS Foundation Trust

Metropolitan Borough of Wirral, Merseyside, CH63 4JY, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

St James's University Hospital

Leeds, LS79 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 34671131DERIVED

MeSH Terms

Conditions

Penile Neoplasms

Interventions

vinflunine

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesPenile DiseasesMale Urogenital Diseases

Study Officials

  • Lisa Pickering, MBBS, MRCP

    St George's Healthcare NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2014

First Posted

February 7, 2014

Study Start

March 17, 2014

Primary Completion

November 6, 2018

Study Completion

November 6, 2018

Last Updated

July 23, 2020

Record last verified: 2018-08

Locations

GB(9)