Continued Treatment With Docetaxel Versus Switch to Cabazitaxel After Minor Prostate Specific Antigen Response to Docetaxel in Patients With Castration-Resistant Metastatic Prostate Cancer (SWITCH)

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: March 30, 2012
Last updated: December 23, 2013
Last verified: December 2013

Primary Objective:

  • To compare the continuation of treatment with docetaxel versus switching to cabazitaxel regarding the time to PSA (Prostatic Specific Antigen) progression (TTP-PSA), in patients with Castration-Resistant Prostate Cancer (CRPC) that, after four cycles of docetaxel, have minor PSA response (defined as a reduction between 1% and 49%) or increase of up to 24% in PSA levels.

Secondary Objectives:

  • PSA response rate
  • Overall survival (OS)
  • Incidence of Adverse Events

Condition Intervention Phase
Prostatic Neoplasms
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Randomized Study of Continuing Treatment With Docetaxel Versus Switching to Cabazitaxel After Minor Prostate Specific Antigen Response to Docetaxel in the First Line Treatment of Patients With Castration-Resistant Metastatic Prostate Cancer.

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Median time to PSA progression [ Time Frame: up to 60 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PSA response rate: Percentage of patients with a decrease of at least 50% in the PSA [ Time Frame: up to 60 days ] [ Designated as safety issue: No ]
  • Overall Survival: Median time elapsed between the date of starting treatment until death by any cause [ Time Frame: up to a maximum of 2 years ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: up to a maximum of 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: August 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Docetaxel
75 mg/m2, administered as a 1-hour intravenous infusion, every 3 weeks
Pharmaceutical form: solution Route of administration: intravenous
Experimental: Cabazitaxel
25 mg/m2, administered as a 1-hour intravenous infusion, every 3 weeks
Pharmaceutical form: solution Route of administration: intravenous

Detailed Description:

Screening: 21days (+7 days) Treatment: until PSA progression Post-treatment Follow-up: 2 years


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion criteria :

  • Documentation of histological prostate cancer;
  • Patients with metastatic CRPC (Castration-Resistant Metastatic Prostate Cancer) who progressed with hormone deprivation, including the withdrawal of antiandrogen-class drugs for at least 4 weeks, and 6 weeks for bicalutamide or if documented that PSA did not decrease during 3 months of this therapy;
  • Documentation of metastasis by imaging (computerized tomography [CT], magnetic resonance imaging [MRI] or bone scan), in patients with PSA < 20 ng/mL at the time of inclusion
  • Provide minor PSA response (characterized by a reduction between 1% and 49%) or increase up to 24% in PSA levels, in relation to the value measured before starting docetaxel therapy, measured at least 7 days after the fourth cycle of docetaxel;
  • Patient has received 4 cycles of docetaxel at a dose of 75 mg/m2 ;
  • ECOG performance status of 0 or 1;
  • Marrow, liver and renal function within acceptable values;
  • PSA ≥ 2 ng/mL;
  • Testosterone level ≤ 50 ng/dL (for patients with no prior history of orchiectomy).

Exclusion criteria:

  • Prior use of chemotherapy, except for docetaxel for four cycles;
  • Documented disease progression during treatment with docetaxel (first 4 cycles);
  • Patients with metastases resulting in neurological damage;
  • Inability to continue receiving gonadotropin-releasing hormone agonists in patients with no prior history of orchiectomy;
  • Use of recombinant methionyl human granulocyte-colony stimulating factor non-glycosylated (G-CSF) in the 24 hours preceding baseline;
  • Any other current neoplasia or over the past 5 years, except for basal cell skin carcinoma or squamous skin cell carcinoma;
  • Known seropositivity for HIV (Human immunodeficiency Virus );
  • Concomitant diseases, such as significant neurological or psychiatric disease; uncontrolled hypercalcemia or any other serious comorbidity;
  • Hypersensitivity or allergy to any of the study treatments.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its identifier: NCT01576029

Investigational Site Number 004
Barretos, Brazil, 14780-480
Investigational Site Number 008
Brasília, Brazil, 70390-150
Investigational Site Number 009
Londrina, Brazil, 86015-520
Investigational Site Number 003
Mogi das Cruzes, Brazil, 0830-500
Investigational Site Number 005
Porto Alegre, Brazil, 90840-440
Investigational Site Number 001
Rio De Janeiro, Brazil, 22260-020
Investigational Site Number 006
Rio De Janeiro, Brazil, 20231-050
Investigational Site Number 007
São Paulo, Brazil, 01246-000
Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi Identifier: NCT01576029     History of Changes
Other Study ID Numbers: CABAZ_L_05933, U1111-1119-8381
Study First Received: March 30, 2012
Last Updated: December 23, 2013
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 22, 2014