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

This is an interventional treatment trial for Penile Neoplasm focused on measuring Recurrent, Locally advanced, Metastatic Read More

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.