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)

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.

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

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Drug: DOCETAXEL (XRP6976); Drug: CABAZITAXEL (XRP6258)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Barretos, Brazil, 14780-480
    • Investigational Site Number 004
  • Brasília, Brazil, 70390-150
    • Investigational Site Number 008
  • Londrina, Brazil, 86015-520
    • Investigational Site Number 009
  • Mogi das Cruzes, Brazil, 0830-500
    • Investigational Site Number 003
  • Porto Alegre, Brazil, 90840-440
    • Investigational Site Number 005
  • Rio De Janeiro, Brazil, 20231-050
    • Investigational Site Number 006
  • Rio De Janeiro, Brazil, 22260-020
    • Investigational Site Number 001
  • São Paulo, Brazil, 01246-000
    • Investigational Site Number 007

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Docetaxel; 75 mg/m2, administered as a 1-hour intravenous infusion, every 3 weeks	Drug: DOCETAXEL (XRP6976); Pharmaceutical form: solution Route of administration: intravenous
EXPERIMENTAL: Cabazitaxel; 25 mg/m2, administered as a 1-hour intravenous infusion, every 3 weeks	Drug: CABAZITAXEL (XRP6258); Pharmaceutical form: solution Route of administration: intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Median time to PSA progression	up to 60 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: March 30, 2012
• First Submitted That Met QC Criteria: April 11, 2012
• First Posted (ESTIMATE): April 12, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 24, 2013
• Last Update Submitted That Met QC Criteria: December 23, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: CABAZ_L_05933; U1111-1119-8381 (OTHER: UTN)