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 range18 Years
SexMALE
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…
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