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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)

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
CABAZITAXEL (XRP6258)
DOCETAXEL (XRP6976)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 004
  • Investigational Site Number 008
  • Investigational Site Number 009
  • Investigational Site Number 003
  • Investigational Site Number 005
  • Investigational Site Number 006
  • Investigational Site Number 001
  • Investigational Site Number 007

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Docetaxel

Cabazitaxel

Arm Description

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

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

Outcomes

Primary Outcome Measures

Median time to PSA progression

Secondary Outcome Measures

PSA response rate: Percentage of patients with a decrease of at least 50% in the PSA
Overall Survival: Median time elapsed between the date of starting treatment until death by any cause
Number of patients with adverse events

Full Information

First Posted
March 30, 2012
Last Updated
December 23, 2013
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01576029
Brief Title
Continued Treatment With Docetaxel Versus Switch to Cabazitaxel After Minor Prostate Specific Antigen Response to Docetaxel in Patients With Castration-Resistant Metastatic Prostate Cancer
Acronym
SWITCH
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

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel
Arm Type
Active Comparator
Arm Description
75 mg/m2, administered as a 1-hour intravenous infusion, every 3 weeks
Arm Title
Cabazitaxel
Arm Type
Experimental
Arm Description
25 mg/m2, administered as a 1-hour intravenous infusion, every 3 weeks
Intervention Type
Drug
Intervention Name(s)
CABAZITAXEL (XRP6258)
Intervention Description
Pharmaceutical form: solution Route of administration: intravenous
Intervention Type
Drug
Intervention Name(s)
DOCETAXEL (XRP6976)
Intervention Description
Pharmaceutical form: solution Route of administration: intravenous
Primary Outcome Measure Information:
Title
Median time to PSA progression
Time Frame
up to 60 days
Secondary Outcome Measure Information:
Title
PSA response rate: Percentage of patients with a decrease of at least 50% in the PSA
Time Frame
up to 60 days
Title
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
Title
Number of patients with adverse events
Time Frame
up to a maximum of 2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 004
City
Barretos
ZIP/Postal Code
14780-480
Country
Brazil
Facility Name
Investigational Site Number 008
City
Brasília
ZIP/Postal Code
70390-150
Country
Brazil
Facility Name
Investigational Site Number 009
City
Londrina
ZIP/Postal Code
86015-520
Country
Brazil
Facility Name
Investigational Site Number 003
City
Mogi das Cruzes
ZIP/Postal Code
0830-500
Country
Brazil
Facility Name
Investigational Site Number 005
City
Porto Alegre
ZIP/Postal Code
90840-440
Country
Brazil
Facility Name
Investigational Site Number 006
City
Rio De Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
Investigational Site Number 001
City
Rio De Janeiro
ZIP/Postal Code
22260-020
Country
Brazil
Facility Name
Investigational Site Number 007
City
São Paulo
ZIP/Postal Code
01246-000
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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