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Penile NeoplasmPhase 2JAVA-PNCT03114254

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

A Phase 2 study testing Cabazitaxel in people with Penile Neoplasm, run by University Hospitals Bristol and Weston NHS Foundation Trust at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Penile Neoplasm
What is being tested?
Cabazitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
2 sitesUnited Kingdom
Study dates
5 Dec 2014to 16 Nov 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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.)

Who cannot join

  • 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
Show all 18Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Bristol Haematology and Oncology Centre, Horfield Road

    Bristol, BS2 8ED

  • Universitty College Hospitals NHS Trust

    London

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Conditions
Penile Neoplasm
Being tested
Cabazitaxel
Keywords
Recurrent, Locally advanced, Metastatic
Medical subject headings
Penile Neoplasms, Recurrence, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CabazitaxelDrug

    Also called Jetvana

    Six cycles of chemotherapy comprising:

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

Study groups in NCT03114254
Study groupRoleWhat they receive
CabazitaxelExperimentalSix cycles of chemotherapy comprising: Cabazitaxel 25mg/m2 to be repeated at intervals of 21 days
Receives: Drug: Cabazitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete response

    Complete response recorded from the start of the treatment to completion of 6 cy-cles of treatment determined by radiological response assessment

    Measured: 18 weeks

  2. Partial response

    Partial response recorded from the start of the treatment to completion of 6 cy-cles of treatment determined by radiological response assessment

    Measured: 18 weeks

Secondary outcomes (4)

  1. Progression free survival

    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

    Measured: Until patient progresses, which is approximately 6 weeks after randomisation

  2. Overall survival

    Overall survival defined as time from registration to the date of death due to from any cause

    Measured: Until patient dies, which is approximately 3 months after randomisation

  3. Acute toxicity (Defined by number of CTCAE v4.03 Adverse Events, Adverse Reactions and by grades and the worst grade).

    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. .

    Measured: After each cycle (every 3 weeks) for maximally 6 cycles therefore 18 weeks whilst on treatment and at the 3 month visit timepoint

  4. Late toxicity (Defined by number of CTCAE v4.03 Adverse Events, Adverse Reactions and by grades and the worst grade).

    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. .

    Measured: From 3 months post treatment Cycle 1 Day 1 to up to 6 months recorded at the 3 month and 6 month timepoint.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2017
  2. Study start5 Dec 2014
  3. Primary completion16 Nov 2016
  4. Study completion16 Nov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03114254
Sponsor's protocol ID
ON/2012/4233
Other IDs
2014-002336-14, CabazL05881, 2014
Acronym
JAVA-P
Status last verified
Nov 2022
First submitted
30 Oct 2014
Last updated
18 Nov 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Seixas AL, Ornellas AA, Marota A, Wisnescky A, Campos F, de Moraes JR. Verrucous carcinoma of the penis: retrospective analysis of 32 cases. J Urol. 1994 Nov;152(5 Pt 1):1476-8; discussion 1478-9. doi: 10.1016/s0022-5347(17)32450-3.

    PubMed 7933188

  • Soria JC, Fizazi K, Piron D, Kramar A, Gerbaulet A, Haie-Meder C, Perrin JL, Court B, Wibault P, Theodore C. Squamous cell carcinoma of the penis: multivariate analysis of prognostic factors and natural history in monocentric study with a conservative policy. Ann Oncol. 1997 Nov;8(11):1089-98. doi: 10.1023/a:1008248319036.

    PubMed 9426328

  • Cubilla AL, Ayala MT, Barreto JE, Bellasai JG, Noel JC. Surface adenosquamous carcinoma of the penis. A report of three cases. Am J Surg Pathol. 1996 Feb;20(2):156-60. doi: 10.1097/00000478-199602000-00003.

    PubMed 8554104

  • Somogyi L, Kalman E. Metaplastic carcinoma of the penis. J Urol. 1998 Dec;160(6 Pt 1):2152-3. doi: 10.1097/00005392-199812010-00059. No abstract available.

    PubMed 9817349

  • Tomic S, Warner TF, Messing E, Wilding G. Penile Merkel cell carcinoma. Urology. 1995 Jun;45(6):1062-5. doi: 10.1016/s0090-4295(99)80134-4.

    PubMed 7771012

  • Kim ED, Kroft S, Dalton DP. Basal cell carcinoma of the penis: case report and review of the literature. J Urol. 1994 Nov;152(5 Pt 1):1557-9. doi: 10.1016/s0022-5347(17)32471-0.

    PubMed 7933201

  • Bundrick WS, Culkin DJ, Mata JA, Gonzalez E, Zitman R, Venable DD. Penile malignant melanoma in association with squamous cell carcinoma of the penis. J Urol. 1991 Nov;146(5):1364-5. doi: 10.1016/s0022-5347(17)38096-5.

    PubMed 1942294

  • Oppenheim AR. Sebaceous carcinoma of the penis. Arch Dermatol. 1981 May;117(5):306-7. No abstract available.

    PubMed 7224661

  • Wood EW, Gardner WA Jr, Brown FM. Spindle cell squamous carcinoma of the penis. J Urol. 1972 Jun;107(6):990-1. doi: 10.1016/s0022-5347(17)61190-x. No abstract available.

    PubMed 5033986

  • Srinivas V, Morse MJ, Herr HW, Sogani PC, Whitmore WF Jr. Penile cancer: relation of extent of nodal metastasis to survival. J Urol. 1987 May;137(5):880-2. doi: 10.1016/s0022-5347(17)44281-9.

    PubMed 3573181

  • Ravi R. Correlation between the extent of nodal involvement and survival following groin dissection for carcinoma of the penis. Br J Urol. 1993 Nov;72(5 Pt 2):817-9. doi: 10.1111/j.1464-410x.1993.tb16273.x.

    PubMed 8281416

  • Slaton JW, Morgenstern N, Levy DA, Santos MW Jr, Tamboli P, Ro JY, Ayala AG, Pettaway CA. Tumor stage, vascular invasion and the percentage of poorly differentiated cancer: independent prognosticators for inguinal lymph node metastasis in penile squamous cancer. J Urol. 2001 Apr;165(4):1138-42.

    PubMed 11257655

  • Solsona E, Iborra I, Rubio J, Casanova JL, Ricos JV, Calabuig C. Prospective validation of the association of local tumor stage and grade as a predictive factor for occult lymph node micrometastasis in patients with penile carcinoma and clinically negative inguinal lymph nodes. J Urol. 2001 May;165(5):1506-9.

    PubMed 11342906

  • Hussein AM, Benedetto P, Sridhar KS. Chemotherapy with cisplatin and 5-fluorouracil for penile and urethral squamous cell carcinomas. Cancer. 1990 Feb 1;65(3):433-8. doi: 10.1002/1097-0142(19900201)65:33.0.co;2-g.

    PubMed 2297633

  • Shammas FV, Ous S, Fossa SD. Cisplatin and 5-fluorouracil in advanced cancer of the penis. J Urol. 1992 Mar;147(3):630-2. doi: 10.1016/s0022-5347(17)37327-5.

    PubMed 1538445

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cabazitaxel in people with Penile Neoplasm, run by University Hospitals Bristol and Weston NHS Foundation Trust at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response (time frame: 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03114254, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.

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