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

Sponsor
University Hospitals Bristol and Weston NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT03114254
Collaborator
Sanofi (Industry)
17
Enrollment
2
Locations
1
Arm
23.4
Actual Duration (Months)
8.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
N/A
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 :
Dec 5, 2014
Actual Primary Completion Date :
Nov 16, 2016
Actual Study Completion Date :
Nov 16, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Complete response [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 [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 [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 [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). [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). [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. .

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bristol Haematology and Oncology Centre, Horfield Road Bristol United Kingdom BS2 8ED
    2 Universitty College Hospitals NHS Trust London United Kingdom

    Sponsors and Collaborators

    • University Hospitals Bristol and Weston NHS Foundation Trust
    • Sanofi

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University Hospitals Bristol and Weston NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT03114254
    Other Study ID Numbers:
    • ON/2012/4233
    • 2014-002336-14
    • CabazL05881
    First Posted:
    Apr 14, 2017
    Last Update Posted:
    Apr 14, 2017
    Last Verified:
    Apr 1, 2017
    Keywords provided by University Hospitals Bristol and Weston NHS Foundation Trust
    Recurrent
    Locally advanced
    Metastatic
    Additional relevant MeSH terms:
    Penile Neoplasms

    Study Results

    No Results Posted as of Apr 14, 2017