Clinical Trial: A Trial of Cabazitaxel Chemotherapy in Relapsed Locally Advanced &/or Metastatic Carcinoma of the Penis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Trial of Cabazitaxel Chemotherapy in Relapsed Locally Advanced &/or Metastatic Carcinoma of the Penis

Brief Summary: An evaluation of the activity of cabazitaxel chemotherapy in relapsed cancer of the penis. Safety and tolerability will be monitored and survival will be assessed. It is hypothesised that cabazitaxel is useful in increasing progression free survival in relapsed penile cancer.

Detailed Summary: First line treatment of penile cancer often combines Docetaxel, Cisplatin and 5Fluouracil (5FU) and there is currently no United Kingdom standard second line agent. Carbazitaxel has been shown to kill both taxane resistant and sensitive cells. JAVA-P is a phase two, single arm study of the use of carbazitaxel for relapsed, locally advanced or metastatic carcinoma of the penis. Seventeen patients will be recruited over two years, with adverse events and progression free survival being assessed. Results may indicate the need for larger studies to evaluate carbazitaxel as a first line agent.
Sponsor: University Hospitals Bristol NHS Foundation Trust

Current Primary Outcome:

• Complete response [ Time Frame: 18 weeks ]
  Complete response recorded from the start of the treatment to completion of 6 cy-cles of treatment determined by radiological response assessment
• Partial response [ Time Frame: 18 weeks ]
  Partial response recorded from the start of the treatment to completion of 6 cy-cles of treatment determined by radiological response assessment

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Progression free survival [ Time Frame: Until patient progresses, which is approximately 6 weeks after randomisation ]
  Progression free survival defined as the time from registration to the first of one of the following: development of radiological disease progression (RECIST 1.1) or death from any cause
• Overall survival [ Time Frame: Until patient dies, which is approximately 3 months after randomisation ]
  Overall survival defined as time from registration to the date of death due to from any cause
• Acute toxicity (Defined by number of CTCAE v4.03 Adverse Events, Adverse Reactions and by grades and the worst grade). [ Time Frame: After each cycle (every 3 weeks) for maximally 6 cycles therefore 18 weeks whilst on treatment and at the 3 month visit timepoint ]
  Acute toxicity (Defined by number of CTCAE v4.03 Adverse Events, Adverse reactions and by grades experienced by the patient collected at study visits and recorded on an Adverse Event Case report form. .
• Late toxicity (Defined by number of CTCAE v4.03 Adverse Events, Adverse Reactions and by grades and the worst grade). [ Time Frame: From 3 months post treatment Cycle 1 Day 1 to up to 6 months recorded at the 3 month and 6 month timepoint. ]
  Late toxicity (Defined by number of CTCAE v4.03 Adverse Events, Adverse reactions and by grades experienced by the patient collected at study visits and recorded on an Adverse Event Case report form. .

Original Secondary Outcome: Same as current

Information By: University Hospitals Bristol NHS Foundation Trust

Dates:
Date Received: October 30, 2014
Date Started: December 5, 2014
Date Completion:
Last Updated: April 10, 2017
Last Verified: April 2017