A Randomized Trial of Standard Treatment with Cabazitaxel Once Every Three Weeks Compared to a Regimen of Cabazitaxel Given Weekly for Five of Six Consecutive Weeks in Patients With Prostate Cancer that has Spread

Phase 1

• Conditions: Metastatic Castration Resistant Prostate Cancer; MedDRA version: 14.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10036920Term: Prostate cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-004178-27-SE
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-19
• Last Update Posted: 27 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 130

Inclusion Criteria

•Written informed consent
•Histological confirmed prostate cancer
•Macroscopic metastatic disease
•Prior treatment with Docetaxel
•Castration resistant disease defined as :
Serum testosterone (< 0.5 ng/ml) and :
* Increase in measurable disease (Recist 1.1) Or
* Appearance of new lesions
Or
* Rising PSA

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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

•Less than 21 days since prior treatment with chemotherapy,
•Less than 14 days since radiotherapy or surgery to the start of cabazitaxel
•Less than 4 weeks after stopping abiraterone or other new anti-hormonal drugs
•Prior isotope therapy or radiotherapy to > 30% of bone marrow (whole pelvic radiotherapy is not an exclusion criteria)
•Adverse events from previous cancer therapies > grade 1 (NCI CTCAE V4.03) with the exception of alopecia. (With respect to peripheral neuropathy grade 2 is acceptable)
•Age less than 18 years
•ECOG performance status > 2
•Known CNS malignancy
•Within 6 months of randomization: myocardial infarction , unstable angina, angioplasty, bypass surgery, stroke, TIA, or congestive heart failure NYHA class III or IV
•Within 3 months prior to randomization: treatment resistant peptic ulcer disease, infectious or inflammatory bowel disease, pulmonary embolism
•Any severe acute or chronic medical condition that places the patient at increased risk of serious toxicity or interferes with the interpretation of study results
•Unable to comply with study procedures
•History of hypersensitivity to docetaxel or polysorbate 80
•Inadequate organ and bone marrow function as defined below
•Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5 ( eg simvastatin, keotconazole. For comprehensive list please see Appendix ) a one week wash out period is necessary for patients who are already on these treatments).
•Patients with reproductive potential not implementing accepted and effective method of contraception.

Study & Design

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