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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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).

Detailed Summary:
Sponsor: Institute of Cancer Research, United Kingdom

Current Primary Outcome: Clinical Benefit [ Time Frame: 12 weeks ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Objective Response Rate [ Time Frame: 12 weeks ]
    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) ]
    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 ]
    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 ]
    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 ]
    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.


Original Secondary Outcome: Same as current

Information By: Institute of Cancer Research, United Kingdom

Dates:
Date Received: February 5, 2014
Date Started: March 2014
Date Completion: September 2018
Last Updated: May 22, 2017
Last Verified: May 2017