Condition category
Cancer
Date applied
26/03/2013
Date assigned
26/03/2013
Last edited
14/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

12/02/2016

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. Patient’s 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

http://www.birmingham.ac.uk/researchsupportgroup

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

Publication citations

Additional files

Editorial Notes

14/11/2016: the overall trial end date was changed from 30/06/2015 to 12/02/2016.