Cabazitaxel chemotherapy for advanced and/or metastatic cancer of the penis.
- Conditions
- Relapsed, locally advanced and/or metastatic carcinoma of the penis.MedDRA version: 17.0 Level: PT Classification code 10007384 Term: Carcinoma in situ of penis System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-002336-14-GB
- Lead Sponsor
- niversity Hosptial Bristol NHS Foundation trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 9
Written informed consent
Male = 18 years
Histologically proven squamous cell carcinoma of the penis
Stage:
M1 or
M0 Tx N3 or
M0 Tx N2 and deemed inoperable by MDT or
M0 T3 N1 or
M0 T4 any N
ECOG =2
Previous frist line chemotherapy with either TPF (Docetaxel, Cisplatin and 5 Flurouracil) or Cisplatin + 5FU
Measurable disease
Adequate organ function as evidenced by the following peripheral blood counts and serum biochemistry at enrolment:
oNeutrophils =1.5 x 109/L
oHaemoglobin =10 g/dL
oPlatelets =100 x 109/L
oTotal bilirubin <1.5 upper limit of normal (ULN)
oAlanine 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 17
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Pure verrucous carcinoma of the penis
Squamous cell carcinoma of the penis
T1 N1 M0 disease
T2 N1 M0 disease
Unfit for this regimen as assessed at MDT
Contraindication to chemotherapy
ECOG > 2
Active peripheral neuropathy grade = 2
Active secondary cancers
Other concurrent serious illness or medical condition
Inadequate organ function
ECG evidence of uncontrolled cardiac arrythmias, angina pectoris and/or hypertension, history of congestive heart failure or myocardial infarctoin within the 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
Particpation in another clinical trial with an 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method