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Locally-advanced or Metastatic Penile NeoplasmsPhase 2VinCaPNCT02057913

A Phase II Trial of Vinflunine Chemotherapy in Locally-advanced and Metastatic Carcinoma of the Penis (VinCaP)

A Phase 2 study testing Vinflunine in people with Locally-advanced or Metastatic Penile Neoplasms, run by Institute of Cancer Research, United Kingdom at 9 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Vinflunine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
9 sitesUnited Kingdom
Study dates
17 Mar 2014to 6 Nov 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.
  • Written, informed consent.

Who cannot join

  • 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).
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  • 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:
  • are INELIGIBLE if the involved lymph nodes are the only site of disease.
  • are ELIGIBLE if they have other measurable sites of disease e.g. pulmonary metastases.
  • If uncertain, please discuss with the Chief Investigator.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United Kingdom9 sites

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • St James's University Hospital

    Leeds, LS79 7TF

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

  • University College London Hospitals NHS Foundation Trust

    London, Greater London, NW1 2PG

  • The Christie NHS Foundation Trust

    Manchester, Greater Manchester, M20 4BX

  • Clatterbridge Centre for Oncology NHS Foundation Trust

    Metropolitan Borough of Wirral, Merseyside, CH63 4JY

  • St George's Healthcare NHS Trust

    Tooting, London, SW17 0QT

  • Royal Cornwall Hospitals NHS Trust

    Truro, Cornwall, TR1 3LJ

  • Velindre NHS Trust

    Whitchurch, Cardiff, CF14 2TL

Other trials in United Kingdom

About this study

Official title: A Phase II Trial of Vinflunine Chemotherapy in Locally-advanced and Metastatic Carcinoma of the Penis

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).

Being tested
Vinflunine
Keywords
Penile neoplasms, Chemotherapy, Vinflunine, Phase II
Medical subject headings
Penile Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VinflunineDrug

    Also called Javlor

    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.

Study groups in NCT02057913
Study groupRoleWhat they receive
VinflunineExperimentalAll 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.
Receives: Drug: Vinflunine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Secondary outcomes (5)

  1. Objective Response Rate

    Proportion of patients having achieved partial or complete remission. The proportion of patients with objective response will be calculated and presented along its 95% confidence interval.

    Measured: 12 weeks

  2. Toxicity

    Toxicity will be evaluated, using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4 scoring, after each cycle, at the end of treatment and at follow up visits. The proportion of patients experiencing grade 3 or 4 toxicities at these time points and until progression will be reported as well as the Serious Adverse Events (SAEs).

    Measured: 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)

  3. Progression-free survival

    Progression-free survival will be defined as time from registration until the first of clinically or radiologically documented disease progression, or death from any cause death. Patients alive and progression-free at time of analysis will be censored at date last seen.

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

  4. Overall Survival

    Patients alive at time of analysis will be censored at date last seen. Patients lost to follow-up will be censored at date last seen.

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

  5. Treatment Compliance

    Treatment Compliance will be defined as proportion of planned doses delivered. Reasons for non-delivery of planned doses (patient or clinician preference, toxicity and tolerability) will be collected.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2014 (estimated)
  2. Study start17 Mar 2014
  3. Primary completion6 Nov 2018
  4. Study completion6 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02057913
Sponsor's protocol ID
ICR-CTSU/2012/10036
Other IDs
CRUK/12/021, 2012-002592-34, 13/LO/0822, CCR3858
Acronym
VinCaP
Status last verified
Aug 2018
First submitted
5 Feb 2014
Last updated
23 Jul 2020
Results posted
No

Publications

  • 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.

    PubMed 34671131

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vinflunine in people with Locally-advanced or Metastatic Penile Neoplasms, run by Institute of Cancer Research, United Kingdom at 9 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Benefit (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02057913, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.

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