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

NCT ID: NCT01576029

Last Updated: 2013-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-12-31

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

Conditions

Prostatic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Docetaxel

75 mg/m2, administered as a 1-hour intravenous infusion, every 3 weeks

Group Type: ACTIVE_COMPARATOR

DOCETAXEL (XRP6976)

Intervention Type: DRUG

Pharmaceutical form: solution Route of administration: intravenous

Cabazitaxel

25 mg/m2, administered as a 1-hour intravenous infusion, every 3 weeks

Group Type: EXPERIMENTAL

CABAZITAXEL (XRP6258)

Intervention Type: DRUG

Pharmaceutical form: solution Route of administration: intravenous

Interventions

CABAZITAXEL (XRP6258)

Pharmaceutical form: solution Route of administration: intravenous

Intervention Type: DRUG

DOCETAXEL (XRP6976)

Pharmaceutical form: solution Route of administration: intravenous

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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 006

Rio de Janeiro, , Brazil

Investigational Site Number 001

Rio de Janeiro, , Brazil

Investigational Site Number 007

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

U1111-1119-8381

Identifier Type: OTHER

Identifier Source: secondary_id

CABAZ_L_05933

Identifier Type: -

Identifier Source: org_study_id