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Trial record 55 of 117 for:    "Penile Disease"

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

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ClinicalTrials.gov Identifier: NCT03114254
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
University Hospitals Bristol NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Penile Neoplasm Drug: Cabazitaxel Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Cabazitaxel Chemotherapy in Relapsed Locally Advanced &/or Metastatic Carcinoma of the Penis
Actual Study Start Date : December 5, 2014
Actual Primary Completion Date : November 16, 2016
Actual Study Completion Date : November 16, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Cabazitaxel

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 Name: Jetvana




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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. .

  4. 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. .



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114254


Locations
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United Kingdom
Bristol Haematology and Oncology Centre, Horfield Road
Bristol, United Kingdom, BS2 8ED
Universitty College Hospitals NHS Trust
London, United Kingdom
Sponsors and Collaborators
University Hospitals Bristol NHS Foundation Trust
Sanofi
Investigators
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Principal Investigator: Amit Bahl University Hospitals Bristol NHS Foundation Trust

Publications:

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Responsible Party: University Hospitals Bristol NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03114254     History of Changes
Other Study ID Numbers: ON/2012/4233
2014-002336-14 ( EudraCT Number )
CabazL05881 ( Other Grant/Funding Number: Sanofi )
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017

Keywords provided by University Hospitals Bristol NHS Foundation Trust:
Recurrent
Locally advanced
Metastatic

Additional relevant MeSH terms:
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Penile Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Penile Diseases