Clinical trial NCT01576029: Continued Treatment With Docetaxel Versus Switch to Cabazitaxel After Minor Prostate Specific Antigen Response to Docetaxel in Patients With Castration-Resistant Metastatic Prostate Cancer
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-04-12
Enrollment: 2
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Median time to PSA progression
timeFrame: up to 60 days
Secondary outcomes:
measure: PSA response rate: Percentage of patients with a decrease of at least 50% in the PSA
timeFrame: up to 60 days
measure: Overall Survival: Median time elapsed between the date of starting treatment until death by any cause
timeFrame: up to a maximum of 2 years
measure: Number of patients with adverse events
timeFrame: up to a maximum of 2 years
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Investigational Site Number 004
city: Brasília
country: Brazil
facility: Investigational Site Number 008
city: Londrina
country: Brazil
facility: Investigational Site Number 009
city: Mogi das Cruzes
country: Brazil
facility: Investigational Site Number 003
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 005
city: Rio De Janeiro
country: Brazil
facility: Investigational Site Number 006
city: Rio De Janeiro
country: Brazil
facility: Investigational Site Number 001
city: São Paulo
country: Brazil
facility: Investigational Site Number 007
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: