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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01576029
First received: March 30, 2012
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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

Condition Intervention Phase
Prostatic Neoplasms
Drug: CABAZITAXEL (XRP6258)
Drug: DOCETAXEL (XRP6976)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Median time to PSA progression [ Time Frame: up to 60 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PSA response rate: Percentage of patients with a decrease of at least 50% in the PSA [ Time Frame: up to 60 days ] [ Designated as safety issue: No ]
  • Overall Survival: Median time elapsed between the date of starting treatment until death by any cause [ Time Frame: up to a maximum of 2 years ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: up to a maximum of 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: August 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576029

Locations
Brazil
Investigational Site Number 004
Barretos, Brazil, 14780-480
Investigational Site Number 008
Brasília, Brazil, 70390-150
Investigational Site Number 009
Londrina, Brazil, 86015-520
Investigational Site Number 003
Mogi das Cruzes, Brazil, 0830-500
Investigational Site Number 005
Porto Alegre, Brazil, 90840-440
Investigational Site Number 001
Rio De Janeiro, Brazil, 22260-020
Investigational Site Number 006
Rio De Janeiro, Brazil, 20231-050
Investigational Site Number 007
São Paulo, Brazil, 01246-000
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01576029     History of Changes
Other Study ID Numbers: CABAZ_L_05933, U1111-1119-8381
Study First Received: March 30, 2012
Last Updated: December 23, 2013
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014