A Trial of Cabazitaxel Chemotherapy in Relapsed Locally Advanced &/or Metastatic Carcinoma of the… (NCT03114254) | Clinical Trial Compass
CompletedPhase 2
A Trial of Cabazitaxel Chemotherapy in Relapsed Locally Advanced &/or Metastatic Carcinoma of the Penis
United Kingdom17 participantsStarted 2014-12-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 mel…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete response
Timeframe: 18 weeks
2
Partial response
Timeframe: 18 weeks
Trial details
NCT IDNCT03114254
SponsorUniversity Hospitals Bristol and Weston NHS Foundation Trust