Chemotherapy with cabazitaxel in advanced prostate cancer

• Conditions: This study is designed to evaluate the safety of biweekly cabazitaxel for the treatment of metastatic castration resistant prostate cancer (mCRPC) previously treated with docetaxel containing regimen.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-003156-39-FI
• Lead Sponsor: Tampere University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-12
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

- Metastatic castration resistant prostate cancer
- Disease progression during or after docetaxel-containing regimen for mCRPC
- Surgical or medical castration
- WHO performance status < or = 2
- Age > 18 years
- Adequate bone marrow, liver and renal functions:
Hematology:
- neutrophils > 1.5 x 109/ l
- hemoglobin > 100 g/l
- platelets > 100 x 109/l
Hepatic function:
- total bilirubin < or = 1 x UNL
- ALAT and ASAT < 2.5 x UNL, Alkaline Phosphate < or = 6 x UNL. In the presence of extensive bone disease, alkaline phosphate > 6 x UNL is accepted
Renal function:
-Creatinine < 1.5 x UNL (ie NCI grade < 1)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment
- Prior therapy with radioisotopes
- Other malignant disease/ malignancy (except superficial non-melanoma skin cancer) within the past 5 years
- Serious liver disease
- History of severe hypersensitivity reaction (grade > 3) to polysorbate 80 containing drugs
- Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who already are on these treatments)
- Other serious illness or medical condition:
(a) Serious cardiac disease; ischemic or thromboembolic cardiac disease, pulmonary
emboli, cardiac infarction within 12 months
(b) Active infection
(c) Active peptic ulcer, uncontrolled diabetes mellitus or other contraindications for the use
of corticosteroids
(d) Auto-immune disease (lupus, scleroderma, rheumatoid polyarthritis)
(e) Active grade > 2 polyneuropathy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified