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

NCT01576029 | Completed Phase 2

• 2 other identifiers: CABAZ_L_05933U1111-1119-8381
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 8

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

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Median time to PSA progression

  up to 60 days

Secondary Outcomes (3)

• PSA response rate: Percentage of patients with a decrease of at least 50% in the PSA

  up to 60 days

• Overall Survival: Median time elapsed between the date of starting treatment until death by any cause

  up to a maximum of 2 years

• Number of patients with adverse events

  up to a maximum of 2 years

Study Arms (2)

Docetaxel

ACTIVE COMPARATOR

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

Drug: DOCETAXEL (XRP6976)

Cabazitaxel

EXPERIMENTAL

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

Drug: CABAZITAXEL (XRP6258)

Interventions

CABAZITAXEL (XRP6258) DRUG

Pharmaceutical form: solution Route of administration: intravenous

Cabazitaxel

DOCETAXEL (XRP6976) DRUG

Pharmaceutical form: solution Route of administration: intravenous

Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (8)

Investigational Site Number 004

Barretos, 14780-480, Brazil

Location

Investigational Site Number 008

Brasília, 70390-150, Brazil

Location

Investigational Site Number 009

Londrina, 86015-520, Brazil

Location

Investigational Site Number 003

Mogi das Cruzes, 0830-500, Brazil

Location

Investigational Site Number 005

Porto Alegre, 90840-440, Brazil

Location

Investigational Site Number 006

Rio de Janeiro, 20231-050, Brazil

Location

Investigational Site Number 001

Rio de Janeiro, 22260-020, Brazil

Location

Investigational Site Number 007

São Paulo, 01246-000, Brazil

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

cabazitaxel; XRP6258; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2012
• First Posted: April 12, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 24, 2013

Record last verified: 2013-12

Locations

BR (8)