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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Institute of Cancer Research, United Kingdom
Sponsor:
Collaborator:
St George's Healthcare NHS Trust
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier:
NCT02057913
First received: February 5, 2014
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention Phase
Locally-advanced or Metastatic Penile Neoplasms
Drug: Vinflunine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Vinflunine Chemotherapy in Locally-advanced and Metastatic Carcinoma of the Penis

Resource links provided by NLM:


Further study details as provided by Institute of Cancer Research, United Kingdom:

Primary Outcome Measures:
  • Clinical Benefit [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ 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) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: From registration to first documented disease progression or death from any cause, up to 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Time from registration until death from any cause, up to 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 22
Study Start Date: February 2014
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vinflunine
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
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.
Other Name: Javlor

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02057913

Contacts
Contact: VinCaP Trial Manager 02087224261 vincap-icrctsu@icr.ac.uk

Locations
United Kingdom
Velindre NHS Trust Not yet recruiting
Whitchurch, Cardiff, United Kingdom, CF14 2TL
Principal Investigator: Jim Barber, FRCRF MRCP DM MA         
Royal Cornwall Hospitals NHS Trust Not yet recruiting
Truro, Cornwall, United Kingdom, TR1 3LJ
Principal Investigator: Alastair Thomson, BM, MRCP, FRCR, PGCME         
University College London Hospitals NHS Foundation Trust Not yet recruiting
London, Greater London, United Kingdom, NW1 2PG
Principal Investigator: Stephen J Harland, MD, FRCP(UK)         
The Christie NHS Foundation Trust Not yet recruiting
Manchester, Greater Manchester, United Kingdom, M20 4BX
Principal Investigator: Tony Elliott, MBChB FRCR PhD         
St George's Healthcare NHS Trust Not yet recruiting
Tooting, London, United Kingdom, SW17 0QT
Principal Investigator: Lisa Pickering, MBBS, MRCP         
Clatterbridge Centre for Oncology NHS Foundation Trust Not yet recruiting
Wirral, Merseyside, United Kingdom, CH63 4JY
Principal Investigator: John Littler, MRCP(UK) FRCR         
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
St George's Healthcare NHS Trust
Investigators
Principal Investigator: Lisa Pickering, MBBS, MRCP St George's Healthcare NHS Trust
  More Information

Additional Information:
No publications provided

Responsible Party: Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT02057913     History of Changes
Other Study ID Numbers: ICR-CTSU/2012/10036, CRUK/12/021, 2012-002592-34, 13/LO/0822, CCR3858
Study First Received: February 5, 2014
Last Updated: February 6, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by Institute of Cancer Research, United Kingdom:
Penile neoplasms
Chemotherapy
Vinflunine
Phase II

Additional relevant MeSH terms:
Penile Diseases
Neoplasms
Carcinoma
Penile Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Vinblastine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014