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

Prostatic Neoplasms Clinical Trial

— SWITCH  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01576029
• Other study ID #: CABAZ_L_05933
• Secondary ID: U1111-1119-8381
• Status: Completed
• Phase: Phase 2
• First received: March 30, 2012
• Last updated: December 23, 2013
• Start date: August 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• CABAZITAXEL (XRP6258)
Pharmaceutical form: solution Route of administration: intravenous
• DOCETAXEL (XRP6976)
Pharmaceutical form: solution Route of administration: intravenous

Locations

Country	Name	City	State
Brazil	Investigational Site Number 004	Barretos
Brazil	Investigational Site Number 008	Brasília
Brazil	Investigational Site Number 009	Londrina
Brazil	Investigational Site Number 003	Mogi das Cruzes
Brazil	Investigational Site Number 005	Porto Alegre
Brazil	Investigational Site Number 001	Rio De Janeiro
Brazil	Investigational Site Number 006	Rio De Janeiro
Brazil	Investigational Site Number 007	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median time to PSA progression		up to 60 days	No
Secondary	PSA response rate: Percentage of patients with a decrease of at least 50% in the PSA		up to 60 days	No
Secondary	Overall Survival: Median time elapsed between the date of starting treatment until death by any cause		up to a maximum of 2 years	No
Secondary	Number of patients with adverse events		up to a maximum of 2 years	Yes