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

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.