A Trial of Cabazitaxel Chemotherapy in Relapsed Locally Advanced &/or Metastatic Carcinoma of the Penis (JAVA-P)

November 17, 2022 updated by: University Hospitals Bristol and Weston NHS Foundation Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bristol, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology Centre, Horfield Road
      • London, United Kingdom
        • Universitty College Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Histologically-proven squamous cell carcinoma of the penis
  • Performance status ECOG 0-2
  • Written informed consent
  • Measurable disease as per RECIST 1.1
  • Fit to receive cabazitaxel as second line chemotherapy
  • Previously received TPF or cisplatin-5FU as first line systemic chemotherapy for penile cancer

  • Adequate organ function as evidenced by the following peripheral blood counts and serum biochemistry at enrollment:

    • Neutrophils ≥1.5 x 109/L
    • Haemoglobin ≥10 g/dL
    • Platelets ≥100 x 109/L
    • Total bilirubin <1.5 upper limit of normal (ULN)
    • Alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT) ≤1.5 x ULN
    • Serum creatinine ≤1.5 x ULN. (If creatinine is 1.0-1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with a creatinine clearance <60 ml/min should be excluded.)

Exclusion Criteria:

  • Pure veruccous carcinoma of the penis
  • Squamous carcinoma of the urethra
  • T1 N1 M0 disease
  • T2 N1 M0 disease
  • Unfit for this regimen (as assessed by the multidisciplinary team)
  • Contraindication to chemotherapy
  • ECOG Performance Status > 2
  • Active Grade ≥2 peripheral neuropathy
  • Active secondary cancers
  • Other concurrent serious illness or medical conditions
  • Electrocardiogram (ECG) evidence of uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension, history of congestive heart failure, or myocardial infarction within last 6 months.
  • Uncontrolled diabetes mellitus.
  • History of severe hypersensitivity reaction (≥grade 3) to docetaxel
  • History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs
  • Active infection requiring systemic antibiotic or anti-fungal medication
  • Participation in another clinical trial with any investigational drug within 30 days prior to study registration.
  • Concurrent or planned treatment with strong inhibitors of cytochrome P450 3A4/5. A 1-week washout period is necessary for patients who are already on these treatments.
  • Concurrent or planned treatment with strong inducers of cytochrome P450 3A4/5. A 1-week washout period is necessary for patients who are already on these treatments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cabazitaxel

Six cycles of chemotherapy comprising:

Cabazitaxel 25mg/m2 to be repeated at intervals of 21 days
Drug: Cabazitaxel

Six cycles of chemotherapy comprising:

Cabazitaxel 25mg/m2 to be repeated at intervals of 21 days.

Other Names:
  • Jetvana

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
18 weeks
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
18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Until patient progresses, which is approximately 6 weeks after randomisation
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
Until patient dies, which is approximately 3 months after randomisation
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. .
After each cycle (every 3 weeks) for maximally 6 cycles therefore 18 weeks whilst on treatment and at the 3 month visit timepoint
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. .
From 3 months post treatment Cycle 1 Day 1 to up to 6 months recorded at the 3 month and 6 month timepoint.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Bristol and Weston NHS Foundation Trust

Collaborators

Sanofi

Investigators

  • Principal Investigator: Amit Bahl, University Hospitals Bristol and Weston NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 5, 2014

Primary Completion (ACTUAL)

November 16, 2016

Study Completion (ACTUAL)

November 16, 2016

Study Registration Dates

First Submitted

October 30, 2014

First Submitted That Met QC Criteria

April 10, 2017

First Posted (ACTUAL)

April 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 18, 2022

Last Update Submitted That Met QC Criteria

November 17, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ON/2012/4233
  • 2014-002336-14 (EUDRACT_NUMBER)
  • CabazL05881 (OTHER_GRANT: Sanofi)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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