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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospitals Bristol and Weston NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sanofi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 16, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 16, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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