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

Primary Purpose

Locally-advanced or Metastatic Penile Neoplasms

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Vinflunine
Sponsored by
Institute of Cancer Research, United Kingdom
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally-advanced or Metastatic Penile Neoplasms focused on measuring Penile neoplasms, Chemotherapy, Vinflunine, Phase II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Velindre NHS Trust
  • Royal Cornwall Hospitals NHS Trust
  • University College London Hospitals NHS Foundation Trust
  • The Christie NHS Foundation Trust
  • St George's Healthcare NHS Trust
  • Clatterbridge Centre for Oncology NHS Foundation Trust
  • Beatson West of Scotland Cancer Centre
  • St James's University Hospital
  • Leicester Royal Infirmary

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vinflunine

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.
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.
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.

Full Information

First Posted
February 5, 2014
Last Updated
July 22, 2020
Sponsor
Institute of Cancer Research, United Kingdom
Collaborators
St George's Healthcare NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02057913
Brief Title
A Phase II Trial of Vinflunine Chemotherapy in Locally-advanced and Metastatic Carcinoma of the Penis (VinCaP)
Acronym
VinCaP
Official Title
A Phase II Trial of Vinflunine Chemotherapy in Locally-advanced and Metastatic Carcinoma of the Penis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 17, 2014 (Actual)
Primary Completion Date
November 6, 2018 (Actual)
Study Completion Date
November 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Cancer Research, United Kingdom
Collaborators
St George's Healthcare NHS Trust

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally-advanced or Metastatic Penile Neoplasms
Keywords
Penile neoplasms, Chemotherapy, Vinflunine, Phase II

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vinflunine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vinflunine
Other Intervention Name(s)
Javlor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Benefit
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Objective Response Rate
Description
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.
Time Frame
12 weeks
Title
Toxicity
Description
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).
Time Frame
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)
Title
Progression-free survival
Description
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.
Time Frame
From registration to first documented disease progression or death from any cause, up to 24 months
Title
Overall Survival
Description
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.
Time Frame
Time from registration until death from any cause, up to 24 months
Title
Treatment Compliance
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Written, informed consent. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Pickering, MBBS, MRCP
Organizational Affiliation
St George's Healthcare NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Velindre NHS Trust
City
Whitchurch
State/Province
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Royal Cornwall Hospitals NHS Trust
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
State/Province
Greater London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
St George's Healthcare NHS Trust
City
Tooting
State/Province
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology NHS Foundation Trust
City
Wirral
State/Province
Merseyside
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
St James's University Hospital
City
Leeds
ZIP/Postal Code
LS79 7TF
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34671131
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.
Results Reference
derived
Links:
URL
http://www.icr.ac.uk/research/research_divisions/Clinical_Studies/Clinical_Trials/Clinical_Trials_Disease/CT_Disease_Urological/vincap/22938.shtml
Description
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A Phase II Trial of Vinflunine Chemotherapy in Locally-advanced and Metastatic Carcinoma of the Penis (VinCaP)

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