Contact information
Type
Scientific
Primary contact
Mr Nick Martin
ORCID ID
Contact details
Cancer Research UK Clinical Trials Unit
Institute for Cancer Studies
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
CANTATA@trials.bham.ac.uk
Additional identifiers
EudraCT number
2012-003835-40
ClinicalTrials.gov number
Protocol/serial number
13741
Study information
Scientific title
A multicentre, phase II randomised controlled trial evaluating cabazitaxel versus docetaxel rechallenge for the treatment of metastatic castrate refractory prostate cancer, previously treated with docetaxel at inception of primary hormone therapy
Acronym
CANTATA
Study hypothesis
This study compares the safety and levels of activity of cabazitaxel versus docetaxel re-challenge in patients with metastatic castrate refractory prostate cancer who have been previously exposed to combined docetaxel and androgen deprivation as first-line treatment for advanced prostate cancer.
The difference between treatment arms in terms of the number of patients who have a clinical event (clinical progression or death) will provide the evidence whether the levels of activity of cabazitaxel warrant further investigation in a phase III trial.
Ethics approval
Liverpool Central - North West NRES Committee, 10/12/2012, ref: 12/NW/0792
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Prostate cancer
Intervention
Patients will be randomised to one of the following two treatments (plus 10mg prednisolone daily in either regimen):
1. Cabazitaxel 25mg/m2 3 weekly plus prednisolone for up to 10 cycles
2. Docetaxel 75mg/m2 3 weekly plus prednisolone for up to 10 cycles
Follow Up Length: 24 month(s)
Intervention type
Drug
Phase
Phase II
Drug names
Cabazitaxel, docetaxel
Primary outcome measures
Clinical progression-free survival (CPFS)
Secondary outcome measures
No secondary outcome measures
Overall trial start date
07/03/2013
Overall trial end date
29/04/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Diagnosis of histologically proven prostate adenocarcinoma, that is castrate refractory
2. Previously treated with up to 6 cycles of Docetaxel at the same time (defined as commencing within 3 months) as instigation of primary hormone therapy.
3. Confirmed biochemical, radiological or clinical progression.
4. Metastatic disease
5. Male and female, aged 18 or over
6. WHO performance status grade 0 to 2
7. Adequate organ function as evidenced by:
7.1. ANC >1.5 x109/L
7.2. WBC >3.0 x109/L
7.3. Haemoglobin >10g/dL
7.4. Platelet count > 100 x10^9L
7.5. Total bilirubin <1.0 xULN
7.6. AST/ ALT <1.5 xULN
7.7. GFR >30ml/min (calculated by EDTA clearance, 24h urine collection, or Cockcroft-Gault)
8. Available for long-term follow up
9. Patients written informed consent
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
Planned Sample Size: 138; UK Sample Size: 138; Description: Target recruitment is 138 patients in total, with 69 patients per arm.
Participant exclusion criteria
1. Prior systemic therapy with other chemotherapy drugs
2. Metastatic brain disease or leptomeningeal disease
3. Patients with bilirubin equal to or greater than 1.0 xULN
4. Previous extensive palliative radiotherapy to bone marrow, e.g. hemibody radiotherapy
5. Active grade >=2 peripheral neuropathy (NCI CTC v 4)
6. Active infection requiring systemic antibiotic or antifungal medication
7. Patients with reproductive potential not implementing accepted and effective method of contraception
Recruitment start date
07/03/2013
Recruitment end date
12/01/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
Edgbaston
Birmingham
B15 2TT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Aventis Pharma Ltd T/A Sanofi-Aventis
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Cancer Research UK (UK)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Results of this trial will be submitted for publication in a peer-reviewed journal. The manuscript will be prepared by the Trial Management Group (TMG) and authorship will be determined by mutual agreement.
IPD sharing plan
The datasets generated during and/or analysed during the current study will be stored in a publically available repository in 2017. Repository : European Medicines Agency (EMA)’s European Clinical Trial Database, EudraCT V10. URL : http://eudract.ema.europa.eu
Intention to publish date
31/12/2017
Participant level data
Stored in repository
Results - basic reporting
Publication summary