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

• Status: Completed
• Trial end date: 2016-11-16
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Bristol and Weston NHS Foundation Trust
• Collaborator: Sanofi

Criteria

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.