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

University Hospitals Bristol and Weston NHS Foundation Trust

Status and phase

Completed

Phase 2

Conditions

Penile Neoplasm

Treatments

Drug: Cabazitaxel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03114254

CabazL05881 (Other Grant/Funding Number)

2014-002336-14 (EudraCT Number)

ON/2012/4233

Details and patient eligibility

About

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.

Full description

First line treatment of penile cancer often combines Docetaxel, Cisplatin and 5Fluouracil (5FU) and there is currently no United Kingdom standard second line agent. Carbazitaxel has been shown to kill both taxane resistant and sensitive cells. JAVA-P is a phase two, single arm study of the use of carbazitaxel for relapsed, locally advanced or metastatic carcinoma of the penis. Seventeen patients will be recruited over two years, with adverse events and progression free survival being assessed. Results may indicate the need for larger studies to evaluate carbazitaxel as a first line agent.

Enrollment

17 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.